DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-65 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problems
Abdominal Pain (1685); Insufficient Information (4580)
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Event Date 05/16/2023 |
Event Type
Injury
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Event Description
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It was reported that, the cs300 intra-aortic balloon pump (iabp) units non-datascope balloon ruptured.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was able to reproduce the reported issue.The fse replaced safety disk, crm assembly, fill manifold, purge valve and tubing to resolve the issue.Operation check conducted by the fse.The iabp was released to the customer and cleared for clinical service.
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Manufacturer Narrative
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Aware date updated: 05/16/2023.
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Event Description
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It was reported that during use , the cs300 intra-aortic balloon pump (iabp) this iabp this unit was used as the first device.Device was used with a non-maquet balloon.The balloon of the non-maquet iab catheter was perforated/ruptured and blood was entering into the first iabp unit.The extender tubing of the non-maquet iab catheter was disconnected from the first iabp unit.However, later on, when the non-maquet iab catheter was about to be removed percutaneously from the patient, a clinical engineer connected misguidedly its extender tubing to this iabp unit.Blood was also aspirated in this iabp unit.The extender tubing was disconnected from this iabp unit.Although the nonmaquet iab catheter was attempted to be removed from the patient, it was hard to remove percutaneously.Therefore surgical intervention was performed in order to remove the non maquet iab catheter from the patient.After removal of the non-maquet iab catheter, the patient experienced abdominal pain.Iabp therapy ended and the patient has been monitored.Related complaint to (b)(4) - mfg report # 2249723-2023-02555.
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Search Alerts/Recalls
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