DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3013-65 |
Device Problems
Backflow (1064); Restricted Flow rate (1248); 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 03/22/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that after one day of intra-aortic balloon (iab) therapy, the cs100 intra-aortic balloon pump (iabp) frequently generated a check iab catheter alarm.The drive tube outside the body was checked, but there was no blood seen.Since the alarm occurred again the next day, the iabp was switched to a cs300.Blood was then seen in the tubing and entered the iabp.Therapy was completed so the iab was removed.There was no patient harm or adverse event reported.Related to balloon complaint tw (b)(4).
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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that the alarm was caused by the damage of the concomitant iab catheter and not the unit itself.Also due to the damaged concomitant iab catheter, blood was entered into the console of the unit.In order to solve the issue, the fse replaced the following parts: safety disk, condensate removal module (crm), purge valve assembly, and blood detect tubing.The fse then stated that the repair was completed.
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Search Alerts/Recalls
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