Catalog Number 0684-00-0604 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/02/2019 |
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.(b)(4).Device not returned.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the console generated an iab catheter check alarm frequently.The balloon was removed and replaced.There was no reported injury to the patient.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the console generated an iab catheter check alarm frequently.The balloon was removed and replaced.There was no reported injury to the patient.
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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 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 cs300 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 events cannot be confirmed by the evaluation.A device and 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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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.Complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the console generated an iab catheter check alarm frequently.The balloon was removed and replaced.There was no reported injury to the patient.
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Search Alerts/Recalls
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