Surgical safety update
Cases from the Confidential Reporting System for Surgery
Medication errors 1: excess local anaesthetic resulting in death (a PFD report)
The patient had severe osteoarthritis and underwent hip replacement surgery in a private hospital. Towards the end of the procedure, an infiltration of ropivacaine was used that was in excess of the recommended dose. Upon return to their private room, the patient suffered an unwitnessed cardiac arrest. The patient was resuscitated and transferred to an NHS hospital, where they were found to have sustained irreversible brain damage. The patient died several months later.
The prevention of future death (PFD) report described the issue as follows. The evidence was that it is routine practice before the procedure for the anaesthetist to give oral instructions to the scrub nurse, specifying the type and dose of local anaesthetic to be used to infiltrate the operation site. Towards the end of the operation, the scrub nurse hands the local anaesthetic to the surgeon, who then carries out the infiltration. The intention in this case was for a 0.2% solution of ropivacaine to be diluted 50/50 with normal saline before it was infiltrated. The evidence suggested that this was not done. The result was that excessive ropivacaine was administered by mistake. The evidence at the inquest was that this type of practice is common nationally.
CORESS comments
The advisory board (AB) noted that many surgeons find calculating the safe volume of local anaesthetic (LA) to be challenging, particularly mid-procedure, a problem confounded by the use of two units of measurement, percentage (%) and mg/mL. Presence of a SALG (Safe Anaesthesia Liaison Group) representative was valued at the AB meeting and their response to the coroner noted. The PFD report highlighted the unclear process for the responsibility for prescribing LA; the AB concurred that the lack of a communication protocol for the theatre team and unfamiliarity with conversion between % and mg/mL increased the risk of this error happening again.
It is recommended that the LA drug to be used, and the dose in mg, should be discussed at the ‘team brief’ (scan QR code A for the NatSSIPS guidance), including the calculation of the maximum safe dose for each patient. Ideally, the drug and safe dose should be confirmed at the ‘time out’ and then documented on the theatre whiteboard, which should help to minimise the risks. Those involved in drawing up and administering the drug should be involved in both discussions.
It was noted that LA safety is on the curriculum for surgeons in training. It was also noted that the time the patient spent in recovery and the response (or lack of) to monitoring may have been factors in the tragic outcome for this patient.
Medication errors 2: inadvertently high concentration of heparin
A patient who had undergone a femoral popliteal bypass using a reversed great saphenous vein the previous week was admitted with pain and swelling in the groin. CTA identified bleeding from the proximal anastomosis. The patient was taken to theatre by two experienced consultant vascular surgeons and a vascular registrar. The scrub nurse working the case was also experienced and regularly scrubbed for vascular cases.
The case proceeded according to the pre-operative plan: ipsilateral external iliac control was achieved, and the bypass was found to be bleeding from the anastomosis, where a stitch had likely torn through. The bypass was fully disconnected and the CFA, PFA and SFA were controlled, and 3000 IU of unfractionated heparin were given.
To prevent ‘clot off’ while the bypass was disconnected, a 4Fr arterial catheter was sited into the bypass for administration of an infusion of ‘heparinised saline’ from within the operative field. The operation proceeded without incident though, during closure, it was noted that the patient was bleeding excessively from all ‘raw’ surfaces. A thromboelastogram was performed and the patient’s haemoglobin concentration checked – the patient required two units of packed red cells, two units of cryoprecipitate and two units of fresh frozen plasma.
Whilst completing the operation note, the registrar asked the scrub nurse to confirm the volume and concentration of ‘hep sal’ used in the bypass. At this point it was realised that a heparin concentration of 10,000 units in 1L (10 IU/mL) had been used.
Reporter’s comments
Neither of the consultants nor the registrar were aware of the greater than intended dose of heparin being administered. The person who was aware, the scrub nurse, did not voice any concern or bring to the attention of the operating surgeons the large dose of heparin being administered. The ability of all team members to speak up and voice concerns is critical to maintaining patient safety. For whatever reason in this case, the scrub nurse presumed the two consultants and registrar were aware of the medication they were administering.
CORESS comments
Communication between members of the theatre team must be clear and thorough. Where possible, plans for the administration of intra-operative medication should be clarified at the ‘team brief’ and ‘time out’ with the whole team made aware of when the medication is being given. Documentation on the theatre whiteboard is advised. If unplanned, there should be a clear discussion within the team regarding the medication and dose preparation to reduce the risk of inadvertent overdose or interactions between medications. Pre-filled syringes can help reduce the cognitive burden that increases the risk of such events.
Retained object
A 65-year-old female underwent a total knee replacement. The procedure was straight-forward and the swab counts were recorded as correct at the end of the procedure. The following day, the routine post-op XR revealed that there was a radio-opaque foreign body in the knee joint. The patient returned to theatre for removal of the foreign body, imaging revealing it to be in the supra-patellar pouch. Arthroscopy was undertaken and the foreign body was found to be the radio-opaque thread from a swab.
CORESS comments
Retention of a foreign body is a ‘never event’ and, whilst the case details reported to CORESS were brief, an investigation no doubt resulted. The AB considered factors that may have led to the separation of a thread (or threads) from a swab, such as the quality of the swabs and the possibility that the swab had been cut to reduce it in size. The lesson here is the importance of checking the integrity of any item in the surgical field to minimise the risk, especially items that have been cut or become frayed. If items are cut or trimmed, this should be acknowledged by the whole scrub team.
Difficulties with deep brain stimulation
A 78-year-old female underwent DBS insertion for tremor. Initially the patient had a good response. However, her tremor returned after a few days. The device could not be adequately programmed to control the symptoms to the same degree that had been achieved during awake surgery.
Post-operative CT showed that the DBS leads were positioned 2cm deeper than intended along the planned trajectory. The patient underwent repositioning of the DBS leads, which required a re-run of the whole procedure. The patient had excellent tremor control following repositioning of the leads.
Reporter’s comments
A review of the case identified that the error happened during depth measurement of the permanent electrode after the VIM target had been verified. This was due to use of a new measurement tool, supplied by a different manufacturer, on which the zero point was 2cm above the end of the markings of the scale. The old
scale ended at the zero point. The electrode had been measured to the end of the markings.
CORESS comments
Every single piece of new equipment must be inspected with care to ensure the user is familiar with it and to identify any critical differences to the equipment the surgical team already uses. Standardisation of items, such as medication packaging and equipment, plays a key role in reducing the risk of medical error (though standardisation cannot be assumed). If a significant discrepancy is identified, a report should be sent to the Medicines and Healthcare Products Regulatory Agency (scan code B for details).
- Published cases will be acknowledged by a Certificate of Contribution, which may be included in the contributor’s record of continuing professional development.
- CORESS is an independent charity.
- We are grateful to those who have provided the material for these reports.
- The online reporting form is on our website, www.coress.org. uk, which also includes previous Feedback Reports.
Code A
Code B
Medication errors 1: excess local anaesthetic resulting in death (a PFD report)
The patient had severe osteoarthritis and underwent hip replacement surgery in a private hospital. Towards the end of the procedure, an infiltration of ropivacaine was used that was in excess of the recommended dose. Upon return to their private room, the patient suffered an unwitnessed cardiac arrest. The patient was resuscitated and transferred to an NHS hospital, where they were found to have sustained irreversible brain damage. The patient died several months later.
The prevention of future death (PFD) report described the issue as follows. The evidence was that it is routine practice before the procedure for the anaesthetist to give oral instructions to the scrub nurse, specifying the type and dose of local anaesthetic to be used to infiltrate the operation site. Towards the end of the operation, the scrub nurse hands the local anaesthetic to the surgeon, who then carries out the infiltration. The intention in this case was for a 0.2% solution of ropivacaine to be diluted 50/50 with normal saline before it was infiltrated. The evidence suggested that this was not done. The result was that excessive ropivacaine was administered by mistake. The evidence at the inquest was that this type of practice is common nationally.
CORESS comments
The advisory board (AB) noted that many surgeons find calculating the safe volume of local anaesthetic (LA) to be challenging, particularly mid-procedure, a problem confounded by the use of two units of measurement, percentage (%) and mg/mL. Presence of a SALG (Safe Anaesthesia Liaison Group) representative was valued at the AB meeting and their response to the coroner noted. The PFD report highlighted the unclear process for the responsibility for prescribing LA; the AB concurred that the lack of a communication protocol for the theatre team and unfamiliarity with conversion between % and mg/mL increased the risk of this error happening again.
It is recommended that the LA drug to be used, and the dose in mg, should be discussed at the ‘team brief’ (scan QR code A for the NatSSIPS guidance), including the calculation of the maximum safe dose for each patient. Ideally, the drug and safe dose should be confirmed at the ‘time out’ and then documented on the theatre whiteboard, which should help to minimise the risks. Those involved in drawing up and administering the drug should be involved in both discussions.
It was noted that LA safety is on the curriculum for surgeons in training. It was also noted that the time the patient spent in recovery and the response (or lack of) to monitoring may have been factors in the tragic outcome for this patient.
Medication errors 2: inadvertently high concentration of heparin
A patient who had undergone a femoral popliteal bypass using a reversed great saphenous vein the previous week was admitted with pain and swelling in the groin. CTA identified bleeding from the proximal anastomosis. The patient was taken to theatre by two experienced consultant vascular surgeons and a vascular registrar. The scrub nurse working the case was also experienced and regularly scrubbed for vascular cases.
The case proceeded according to the pre-operative plan: ipsilateral external iliac control was achieved, and the bypass was found to be bleeding from the anastomosis, where a stitch had likely torn through. The bypass was fully disconnected and the CFA, PFA and SFA were controlled, and 3000 IU of unfractionated heparin were given.
To prevent ‘clot off’ while the bypass was disconnected, a 4Fr arterial catheter was sited into the bypass for administration of an infusion of ‘heparinised saline’ from within the operative field. The operation proceeded without incident though, during closure, it was noted that the patient was bleeding excessively from all ‘raw’ surfaces. A thromboelastogram was performed and the patient’s haemoglobin concentration checked – the patient required two units of packed red cells, two units of cryoprecipitate and two units of fresh frozen plasma.
Whilst completing the operation note, the registrar asked the scrub nurse to confirm the volume and concentration of ‘hep sal’ used in the bypass. At this point it was realised that a heparin concentration of 10,000 units in 1L (10 IU/mL) had been used.
Reporter’s comments
Neither of the consultants nor the registrar were aware of the greater than intended dose of heparin being administered. The person who was aware, the scrub nurse, did not voice any concern or bring to the attention of the operating surgeons the large dose of heparin being administered. The ability of all team members to speak up and voice concerns is critical to maintaining patient safety. For whatever reason in this case, the scrub nurse presumed the two consultants and registrar were aware of the medication they were administering.
CORESS comments
Communication between members of the theatre team must be clear and thorough. Where possible, plans for the administration of intra-operative medication should be clarified at the ‘team brief’ and ‘time out’ with the whole team made aware of when the medication is being given. Documentation on the theatre whiteboard is advised. If unplanned, there should be a clear discussion within the team regarding the medication and dose preparation to reduce the risk of inadvertent overdose or interactions between medications. Pre-filled syringes can help reduce the cognitive burden that increases the risk of such events.
Retained object
A 65-year-old female underwent a total knee replacement. The procedure was straight-forward and the swab counts were recorded as correct at the end of the procedure. The following day, the routine post-op XR revealed that there was a radio-opaque foreign body in the knee joint. The patient returned to theatre for removal of the foreign body, imaging revealing it to be in the supra-patellar pouch. Arthroscopy was undertaken and the foreign body was found to be the radio-opaque thread from a swab.
CORESS comments
Retention of a foreign body is a ‘never event’ and, whilst the case details reported to CORESS were brief, an investigation no doubt resulted. The AB considered factors that may have led to the separation of a thread (or threads) from a swab, such as the quality of the swabs and the possibility that the swab had been cut to reduce it in size. The lesson here is the importance of checking the integrity of any item in the surgical field to minimise the risk, especially items that have been cut or become frayed. If items are cut or trimmed, this should be acknowledged by the whole scrub team.
Difficulties with deep brain stimulation
A 78-year-old female underwent DBS insertion for tremor. Initially the patient had a good response. However, her tremor returned after a few days. The device could not be adequately programmed to control the symptoms to the same degree that had been achieved during awake surgery.
Post-operative CT showed that the DBS leads were positioned 2cm deeper than intended along the planned trajectory. The patient underwent repositioning of the DBS leads, which required a re-run of the whole procedure. The patient had excellent tremor control following repositioning of the leads.
Reporter’s comments
A review of the case identified that the error happened during depth measurement of the permanent electrode after the VIM target had been verified. This was due to use of a new measurement tool, supplied by a different manufacturer, on which the zero point was 2cm above the end of the markings of the scale. The old
scale ended at the zero point. The electrode had been measured to the end of the markings.
CORESS comments
Every single piece of new equipment must be inspected with care to ensure the user is familiar with it and to identify any critical differences to the equipment the surgical team already uses. Standardisation of items, such as medication packaging and equipment, plays a key role in reducing the risk of medical error (though standardisation cannot be assumed). If a significant discrepancy is identified, a report should be sent to the Medicines and Healthcare Products Regulatory Agency (scan code B for details).
- Published cases will be acknowledged by a Certificate of Contribution, which may be included in the contributor’s record of continuing professional development.
- CORESS is an independent charity.
- We are grateful to those who have provided the material for these reports.
- The online reporting form is on our website, www.coress.org. uk, which also includes previous Feedback Reports.
Code A
Code B
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