Model Number BEQ-HMOD30000-USA#Q |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/26/2018 |
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.Reference exemption # (b)(4).(b)(4).Device was requested but not yet received.
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Event Description
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According to the customer: the perfusionist spotted a large clot in the outlet of the pediatric quadrox.More information of the territory manager received: spoke with the director of perfusion at (b)(6) hospital and he told me that he thinks the issue is with the heparin that they are receiving from their pharmacy.I think they changed suppliers and they are looking into the products efficacy.The account would like getinge to look at the oxygenator just to rule out any manufacturing issues.The customer changed out the entire circuit.No harm to the patient was reported.(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.The sample was investigated in the laboratory of the manaufacturer.A quadrox-id pediatric with tubes was returned.The sample was contaminated.Tubes removed and disposed of.Oxygenator flushed with water.Clots could be confirmed on the blood outlet side.Sample was cleaned with sodium hypochlorite.Visual inspection of the blood outlet cover and the connector was performed, no other abnormalities were found.Thus the failure could be confirmed.The most probable cause of clotting in this case cold be according to the statement of the customer that they think the issue is with the heparin that they are receiving from their pharmacy.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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Event Description
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Internal reference: (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- (b)(4).
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Search Alerts/Recalls
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