Catalog Number 0684-00-0514 |
Device Problems
Inflation Problem (1310); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2024 |
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 after a smooth insertion, the intra-aortic balloon (iab) was connected to the cs300 intra-aortic balloon pump (iabp).Upon connecting, the augmentation pressure did not rise.Suspecting poor balloon expansion, the catheter was replaced with a new one after 10 minutes.Therapy was continued without further issue.There was no patient harm or adverse event reported.
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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 extender tubing was also retuned.The inner lumen was found occluded with dried blood.The occlusion was able to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated.No alarm sounded from the pump.The reported events cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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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