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Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Injury (2348)
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Event Date 10/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.There was no reported malfunction of iabp.If we receive additional information we will submit supplemental report.Not returned to manufacturing.
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Event Description
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It was reported that after intra-aortic balloon (iab) (ymt30r-01) was placed, there was a lot of bleeding after iab was inserted, so when the bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on (b)(6) 2020.There was no any reported malfunction on intra-aortic balloon pump (iabp).Please refer to related mfg report number 2248146-2020-00587 on the involved intra-aortic balloon (iab).
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Manufacturer Narrative
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It was noted that intra-aortic balloon pump (iabp) therapy was initiated on 2020-10-08 and the event date was (b)(6) 2020.Additionally no repairs were performed on the iabp unit involved in this event.Subsequent to the event, the iabp unit was cleared for use and returned to the customer.Updated fields: a3, b4, g4, g7, h2, h10, h11 corrected fields: b3.
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Event Description
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It was reported that after intra-aortic balloon (iab) (ymt30r-01) was placed, there was a lot of bleeding after iab was inserted, so when the bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on 13th october 2020.There was no any reported malfunction on intra-aortic balloon pump (iabp).Please refer to related mfg report number 2248146-2020-00587 on the involved intra-aortic balloon (iab).
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Search Alerts/Recalls
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