DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).
A getinge service representative reported that this iabp unit was used with a yamato plus 30cc iab which was reported in mfg report number 2248146-2021-00389 (tw#473355).
It was also reported that there was no anomalies or malfunction found on this cardiosave iabp unit.
No blood was observed within the iabp unit, either.
A supplemental report will be submitted when additional information is provided to us.
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Event Description
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It was reported that while removing the reported intra-aortic balloon (iab) catheter from the t-handle with maintaining vacuum by one-way valve, the physician encountered some resistance.
Intra-aortic balloon(iab) therapy was started with this iab.
After approximately three days of intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) console generated a check iab catheter alarm and went into standby mode.
The helium tube was checked and blood was confirmed.
The customer then attempted to remove the iab together with the sheath, but they felt resistance that the iab was caught by the blood vessel wall.
A surgical incision was made and the iab was removed.
It was noted that the patient did not have much calcification.
The patient has been in stable condition.
There was no reported malfunction on the iabp.
A separate report has been submitted for the intra-aortic balloon(iab) under mfg report number 2248146-2021-00389.
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