Model Number BE-HLS 7050#HLS SET |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/31/2018 |
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).
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Event Description
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Incident occurred in a clinical trial.* event type: exchange of hls-set advanced.Event description: immediately after the start of ecmo, the delta p value rose suddenly and remained between 60 and 70.As the cause of the rise in pressure was unknown, doctor suspected a malfunction of the equipment and decided to exchange hls sets (the use period of the defective equipment was within one day.).According to the doctor, health damage accompanying this event did not occur.Patient condition.Patient was weaned off the 1st ecmo on (b)(6) 2018.(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.Importer: maquet medical systems usa.45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The product was requested for return to the manufacturer for laboratory investigation.An hls module 7.0 advanced has been returned.The sample was contaminated.The venting membrane was wet.Clots cannot be confirmed.Sample was cleaned with sodium hypochlorite.Leak test according lv 201 was performed.A leak in the tubing connection of the blood inlet connector could be detected.(no evidence was provided that this failure was noticed within the initial complaint report.) the pump cover has been removed.The fleece cover of the internal sensor on the blood inlet cover has come off and shows a slight discoloration (possibly due to moisture).Behind the soldered contacts a crimped fiber was detected.Thus the failure could be confirmed.The most probable root cause could be that the priming solution dripped out of the un-tight venting membrane and flowed under the pump cover and hit the sensor.The sensor shows no leakage.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.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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