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| No. | Title | Brief description | Causes | Good practice |
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| 1 | Burning smell from device
“personal communication” | Burning smell from home-use ventilation-assist device. No patient harm.
Design: Mains input socket directly soldered to the electronic circuit board, held in place mechanically only by solder connections.
Manufacturing process: cutting connector pins short to prevent pins-to-case contact reduced solder-connection surface area.
Result: arcing across dry-solder joints that had cracked from flexing between socket and circuit board.
Discussions with supplier led to redesign. | Device: design—technical design
(Mains input socket fixed to the circuit board by solder connections)
Device: manufacture (cutting pins short) | Prompt reporting by patient and carer
Receptive supplier when alerted |
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| 2 | Overinfusion by syringe pump
([2]; see also [18])
| Pump infusing at 15 mL/hr despite rate set at 10 mL/hr. Found during routine check.
Pump’s damaged syringe size detector incorrectly detected 50 mL syringe as 30 mL causing higher flow rate.
Inadequate storage, with pumps piled into a box, may have contributed physical damage exacerbated by fluid ingress corroding the size-detector.
Similar incident: missing saddle caused pump to detect as 5 mL a 20 mL syringe [18].
Operator contribution: not confirming correct syringe size at prestart checks. | Device: device failure
Infrastructure: maintenance—inadequate storage
Operator: setting up-preuse checks not carried out | Regularly checking delivered fluid volume during infusion
Prompt staff action |
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| 3 | Failure to pace heart
[2] | Patient’s heart paced by external cardiac pacemaker; vital-signs monitor intermittently alarmed asystole.
Initially ascribed to either poor intracardiac contact between pacemaker lead and heart muscle or low pacemaker output.
Closer inspection revealed insecure connection between pacemaker cable and pacemaker.
Design: connector can work loosely.
Contributing operator errors: failures to assemble tightly and check connection. | Device: device-technical Design (connector type)
Operator: setting up-device assembly connecting securely
Operator: setting up-preuse checks not carried out | Use of vital signs monitor
Prompt action
Open investigation of possible causes |
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| 4 | Mistaken identity and diagnosis
[2] | Patient transfer to coronary care following abnormal diagnostic 12-lead ECG. In CCU heart monitor showed normal ECG.
The abnormal ECG was from a different patient.
The ECG machine displays the current ECG and stores previous recordings.
Instead of printing out the ECG from the current patient, the operator printed out the ECG from the previous recording.
Lack of clear print controls contributed to printing wrong ECG.
Similar incidents have been reported by NHS England in a patient safety alert [16]. | Device: ergonomics
Operator: training—knowledge
Operator: procedures—charting (not recording patient details on ECG)
Operator: procedures
(not ensuring that ECG matched patient) | Checking diagnosis in CCU before delivering medication |
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| 5 | Air embolism
([19]; see also [19, 20])
| Patient died from air embolism.
A cannula, with Luer-Lok connector, was inserted into patient’s vein, preparing for intravenous infusion, but not yet connected to infusion pump.
Patient’s blood pressure (BP) monitored. Hose linking monitor to limb cuff had Luer-Lok connector. Hose disconnected to allow patient to visit bathroom; on return hose was connected to intravenous cannula instead of BP monitor.
At next BP measurement monitor pumped air into patient’s vein instead of BP cuff.
Cannula and cuff had same connectors. | Device: ergonomics (similar connectors on cuff and intravenous cannula)
Operator: setting up—device assembly | |
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| 6 | Overinfusion
[21] | Neonate receiving medication from several syringe pumps.
One pump was set to deliver diamorphine at 0.1 mL/hr, but not started. Two minutes later the pump alarmed “attend-to-me.” Not ready to start infusion, nurse stretched to press the alarm-silence button and was reassured by silenced alarm. Later, pressed START, to commence infusion.
Neonate suffered massive overinfusion; rate was 10.1 mL/hr − 100 * prescribed rate.
When stretching to silence alarm the nurse had inadvertently pressed the “10 mL/hr-increment” instead of “alarm silence” control.
Both controls were located close to each other-pressing either silences the alarm. | Device: ergonomics (proximity of pump controls)
Infrastructure: layout—ergonomics
Operator: setting up—control setting
Operator: setting up—preuse checks not carried out | |
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| 7 | Overinfusion
([4], Case 9.10) | To remove air bubbles from the infusion line prior to attaching to patient, the pump’s infusion rate was increased to its maximum.
After air bubble removal the line was connected to patient.
Pump was started without resetting rate-leading to overinfusion. | Operator: setting up—control setting
Operator: procedure (method of priming line [22])
Operator: procedure
(not checking rate before starting) | |
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| 8 | Delayed defibrillation
([4], Case 10.5) | Following cardiac arrest defibrillation was attempted.
Staff unfamiliarity with defibrillator delayed treatment. New defibrillators had been installed—different type requiring lower energy setting, not consistent with previous protocol.
Lack of staff training and comprehensive device commissioning caused operator confusion. | Infrastructure: procurement and commissioning—lack of training on new device(s)
Operator: training | |
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| 9 | Failure to resuscitate
([15], Case 128950-2009-00277) | Defibrillator unexpectedly switched off during an attempted resuscitation.
Battery was 5 years old and had not been regularly checked, contrary to maker’s instructions. | Infrastructure: maintenance | |
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| 10 | Overinfusion
([15], Case 01950) | Patient, with pain controlled by patient controlled analgesia (PCA) pump, found with slurred speech.
Medication vial was empty, not nearly full as anticipated. Patient had prised the PCA’s protective cover to get extra medication.
Pump included antitamper protections which had been deliberately tampered with. No system can completely protect against deliberate tampering. | Tampering: patient | |
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| 11 | Overinfusion
[23] | Low blood pressure alarm from vital signs monitor-patient receiving medication from infusion pump.
Abrupt BP drop resulted from medication free flow from pump. Free flow caused by incorrectly loaded infusion set
Incident occurred 3 weeks after new pump’s introduction despite intensive operator training that emphasised correct set loading.
Pump mounting hindered visibility of misloaded set, exacerbated by staff distraction in busy operating room. | Device: ergonomics
Infrastructure: layout and mounting—ergonomics
Operator: setting up—device Assembly
Operator: concentrate—distraction | Prompt staff action |
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