Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 01/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that it was initially noted that the knee could not be fully flexed during the surgery.It was discovered that the whole of the patient's thigh distal to the tourniquet was "solid", "turgit", "taut".Approx.1.5 liter of fluid had been forced into the tissues under pressure.The fluid was being run through the dualwave console, main pump tubing and patient extension tubing.There had been an audible warning of high pressure prior to surgical intervention but this had been investigated fully and the pump appeared to be working correctly with no other alarms.Decisions had to be made regarding further emergency surgical intervention due to compression in the thigh.An early discovery and prompt action by the surgical and anaesthetic team meant that no further emergency treatment was needed.Procedure performed was a revision acl reconstruction using patella tendon graft with partial medial menisectomy and lateral extra-articular tenodesis.The procedure was completed successfully, however, surgical technique had to be changed to limit use of diathermy.Decisions had to be made regarding choice of surgical procedure as the original intended operation may not have been possible.
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Manufacturer Narrative
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The complaint was not confirmed.The returned pump was visually inspected and showed a minor scratches at the face of the pump, no other physical damage on the unit was noticed.Further review of the pump sub-assembly and components, showed no issues with the latch door or tubing connector.The pump was assembled with a new ar-6410 tubing, and then tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.
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Search Alerts/Recalls
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