Model Number BEQ-HMOD70000-USA |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been requested for evaluation, but not yet received.A follow-up medwatch will be submitted if additional information becomes available.
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Event Description
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The unit was being primed, and customer noticed a leak on the outlet of the oxygenator.With closer observation there seemed to be a crack by the outlet pigtail.The device had not been connected to the patient yet.The oxygenator was cut out and replaced without incident.(b)(4).
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Manufacturer Narrative
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The product was discarded by the hospital; therefore manufacturer's laboratory investigation was not possible.Trend search: a trackwise trend search was performed for p/n 70105.3824 failure code d-leakage luer outlet side and no additional complaint was found.A sap trend search was performed for p/n 70105.3824 failure code 0105 luer outlet side and one additional complaint was found which is already closed for no product related malfunction confirmed.Due to this information no systemic issue could be determined.Based on this a confirmation of the failure is not possible.Correction: according to the event description the product was exchanged prior to patient use.Corrective action: 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.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action 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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