Model Number BEQ-HLS 7050 USA#HL |
Device Problem
Failure to Prime (1492)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/28/2018 |
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).The product was requested for return to the manufacturer for laboratory investigation but was not received yet.
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Event Description
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It was reported that the cardiohelp disposable was primed and put into use without incident.After patient was put on support the delta number started to rise from 21 upon initiation to 60 going into ambulance and finally aprox.265 when the patient got to the cardiac intensive care unit at (b)(6), at which point the arterial and venous lines were clamped a new primed hls module advanced on a new ch was used to support the patient.No harm to the patient was reported.(b)(4).
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Manufacturer Narrative
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(b)(4).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 product was investigated in the laboratory of the manufacturer.An hls module advanced 7.0 has been returned.The module was contaminated.At delivery on the blood inlet and blood outlet side clots were detected.Oxygenator was cleaned several times with sodium hypochlorite.Since the tests in the complaint laboratory are performed only with water or priming solution a clot formation is impossible.There were no further abnormalities.Thus the failure could be confirmed.The most probable root cause for the reported delt p pressure increase could be the detected clots in the out and inlet connector.According to the investigation report of the laboratory the reported failure "delta p increase" could not be confirmed, because they have to clean the product before the tests has to be performed and the existing clots have to rinsed out.But the clots were detected at delivery therefore a confirmation of the failure is possible even if it cannot be confirmed in the report.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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(b)(4).
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Search Alerts/Recalls
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