Catalog Number IAB-05830-LWS |
Device Problems
Material Rupture (1546); Gas/Air Leak (2946)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: for complaints involving the same patient and event see: mdr #3010532612-2019-00396 and (b)(4), mdr #3010532612-2019-00398 and (b)(4), mdr #3010532612-2019-00399 and (b)(4).
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Event Description
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It was reported by the rn that the intra-aortic balloon pump (iabp) has constant helium loss alarms.The rn called the hotline to discuss the helium loss alarms.The intra-aortic balloon (iab) was inserted in the cath lab and removed immediately due to "so much calcification that the iab was shredded".There was no blood noted in the tubing, helium loss alarms less than 2 minutes apart.A leak test was performed and the iab failed the test.The iabp was exchanged as well as the helium tanks.As a result, the iab was removed and another iab was used.The patient was reported to be stable off the iabp.There was no report of patient complications or consequence.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab helium loss alarm is not confirmed.The returned iab bladder was fully intact with no abnormalities noted.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.No further action required at this time.Other remarks: for complaints involving the same patient and event see: mdr #3010532612-2019-00396 and tc #1900072891, mdr #3010532612-2019-00398 and tc #1900072911, and mdr #3010532612-2019-00399 and tc #1900072912.
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Event Description
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It was reported by the rn that the intra-aortic balloon pump (iabp) has constant helium loss alarms.The rn called the hotline to discuss the helium loss alarms.The intra-aortic balloon (iab) was inserted in the cath lab and removed immediately due to "so much calcification that the iab was shredded".There was no blood noted in the tubing, helium loss alarms less than 2 minutes apart.A leak test was performed and the iab failed the test.The iabp was exchanged as well as the helium tanks.As a result, the iab was removed and another iab was used.The patient was reported to be stable off the iabp.There was no report of patient complications or consequence.
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Search Alerts/Recalls
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