It was reported that the unit had res leak alarm.Red side reservoir cuff is leaking, indicating there is a leak present between the pump and the valves.There was leakage from the port at about 1 lpm.Event occurred during surgery , no harm, no delay reported.It is unknown whether there was any spontaneous deflation.No adverse events were reported as a result of this malfunction.
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.On (b)(6) 2018, it was reported that the unit had a res leak alarm.The red side reservoir cuff is leaking, indicating there is a leak present between the pump and the valves.There was leakage from the port at about 1 lpm.The customer returned an a.T.S.3000 tourniquet device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated a.T.S.3000ts tourniquet serial number (b)(4) as documented in the repair reports in livelink.Product review of the a.T.S.3000 tourniquet on november 21, 2018 revealed that the main cuff reservoir leak was due to a bad inflate clippard valve.The control panel was broken out of the front housing.The display had a bright spot in the center.The limb occlusion pressure (lop) reference cards and rear housing attention label was damaged.Repair of the a.T.S.3000 tourniquet was performed by zimmer biomet surgical on november 21, 2018 which included replacement of the front housing, on/standby button, alarm silence button, display assembly, control panel, clippard valve, lop reference card, and labels.A.T.S.3000 tourniquet, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during product review there was a main cuff reservoir leak due to a bad inflate clippard valve.The cause of the res leak alarm was due to the bad inflate clippard valve.The root cause of the res leak alarm could not be determined with the provided information since it is unknown how the clippard valve became damaged.The issue was resolved with the replaced clippard valve.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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