Catalog Number 0684-00-0575 |
Device Problems
Inflation Problem (1310); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, there was a "blood detected" message.The hospital staff looked at the fluoro, and the iab was not inflating.The iab was replaced and therapy was provided.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Occupation: contracts administrator additional initial reporter: dr.(b)(6).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.Reference complaint: (b)(4).
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded and blood observed on the exterior of the catheter and between the catheter and the sheath.No blood was visible inside the iab catheter.The extender tubing was also returned.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 cadiosave pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported problem 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)(6).
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Event Description
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N/a.
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Search Alerts/Recalls
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