Model Number 0684-00-0480-02 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported that once the intra-aortic balloon (iab) was placed, it was flushed immediately.The iab would not aspirate.A second iab was placed and flushed, but the same issue occurred and the iab would not aspirate.A third iab was inserted without further issue.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab.
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Manufacturer Narrative
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The product has been returned to the manufacturer but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Reference complaint #(b)(4).
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Event Description
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It was reported that once the intra-aortic balloon (iab) was placed, it was flushed immediately.The iab would not aspirate.A second iab was placed and flushed, but the same issue occurred and the iab would not aspirate.A third iab was inserted without further issue.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter the one-way valve attached.A kink was found on the catheter tubing near the y-fitting approximately 76.5cm from the iab tip.The technician was able to successfully aspirate/flush the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported event cannot be confirmed by the evaluation.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall complaint trend data for the period may-19 to apr-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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