Catalog Number IAB-S840C |
Device Problems
Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported a patient of (b)(6) height with an intra-aortic balloon (iab) the pump alarmed after 15 mins use.Helium leak alarm, blood was observed in the catheter.Indicating the balloon was broken.Patient outcome: fine.There was no reported death or complications to the patient.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.Two cuts consistent with contact from a sharp object were found on the bladder membrane which likely allowed blood to enter the helium pathway.Although, the root cause of the bladder damage is undetermined but a potential cause is a result of customer handling.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This issue will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported a patient of 169cm in height with an intra-aortic balloon (iab) the pump alarmed after 15 mins use.Helium leak alarm, blood was observed in the catheter.Indicating the balloon was broken.Patient outcome: fine.There was no reported death or complications to the patient.
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Search Alerts/Recalls
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