DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is: (b)(6).Enter investigation findings a getinge field service engineer (fse) that encountered the issue replaced the blood detect tubing (0008-00-0312), safety disc (0997-00-0985-01) & crm (0997-00-0986-01).All functional and safety checks were performed to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) had a blood back.There was no injury, adverse event or patient involvement.
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Event Description
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N/a.
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Search Alerts/Recalls
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