Model Number BEQ-HLS 7050 USA#HL |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was requested for return to the manufacturer for laboratory investigation but was not received yet.The investigation is still pending.A supplemental medwatch will be submitted after new information has been received.
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Event Description
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It was reported that the customer had a hls disposable which the delta p started to rise.Clotting was suspected.The customer took the circuit apart and no obvious clots on the pre or post side or in the pump was detected.The perfusionist did have a small amount of air on the post side which we were able to pull off with a syringe.The set was exchanged during use and the new one worked fine.Harm to the patient is unknown.(b)(4).
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Manufacturer Narrative
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Maquet medical systems, usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).The product was requested for return to the manufacturer for laboratory investigation.The returned hls module was investigated in the laboratory of the manufacturer.An hls module 70105.4379 beq-015703112#hls module advanced adult was delivered with a dismounted pump unit.The pump was only connected to the oxygenator through the cable of the sensors.The module was cleaned with natriumhypochlorid.A visual inspection was performed.During the inspection it was noticed that the plug from the delta p sensor was no longer fixed on the sensor.Furthermore all screws of the pump cover were missing.The yellow cap of the de-airing membrane was also missing.The delta p sensor shows no abnormalities.The dismounted pump was mounted again to the module.A water cycle was created with the help of a cardiohelp to simulate an functional test.No abnormalities were detected.Thus the failure could not be confirmed.To determine a root cause is not possible at this time, because no failure was detected.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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Event Description
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Internal reference: (b)(4).
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Search Alerts/Recalls
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