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
Gas Leak (2946)
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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 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Type of investigation not yet determined : a supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that during use on a patient, the helium tank status on the cs300 intra-aortic balloon pump (iabp) went from full to empty in a few minutes.
Per icu rn, low helium alarm did not go off.
It was noted that the washer in between the helium tank and iabp unit was removed by a staff member.
There was a clinical change in the patient.
The cs300 iabp unit was replaced with a cardiosave iabp unit and no other issues were noted.
The cath lab director has since replaced the helium tank on the afore mentioned cs300 with a washer in place and has noted no helium issues.
At this time, the customer has not attributed patient harm to the device.
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