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 Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and found blood entered into crm module (0997-00-0986-01), safety disk (0997-00-0985-01), purge assembly (0104-00-0026), and tubing assembly (0008-00-0312) and replaced the same.The fse performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) gave blood detected alarm.Checked and found blood entered into crm, safety disk, purge valve assembly, and blood detect tubing assembly.There was no patient harm reported.
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