DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number UNKNOWN |
Device Problems
Filling Problem (1233); Difficult to Flush (1251); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned, and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint #: (b)(4).
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Event Description
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It was reported that during intra-aortic balloon(iab therapy, the intra-aortic balloon pump (iabp) generated an auto-fill failure alarm.The getinge representative suggested trying to turn iabp off for a few seconds to reset the computer, which we attempted.At first the iabp auto filled and calibrated, but within 30 seconds second alarm appeared with a catheter restriction/kink message.The iab was unable to aspirate or flush.The getinge representative suggested seeking a secondary pressure source such as a radial line, or catheter replacement.Cardiologist on the way; reminded them they could not pull catheter through sheath for fear of shearing balloon, but rather balloon should be pulled back to the sheath, and pulled as one piece.Catheter removed, and was disposed of.Patient was stable without the balloon there was no reported injury, or adverse event to the patient.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
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Manufacturer Narrative
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The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon(iab therapy, the intra-aortic balloon pump (iabp) generated an auto-fill failure alarm.The getinge representative suggested trying to turn iabp off for a few seconds to reset the computer which we attempted.At first the iabp auto filled and calibrated but within 30 seconds second alarm appeared with a catheter restriction/kink message.The iab was unable to aspirate or flush.The getinge representative suggested seeking a secondary pressure source such as a radial line or catheter replacement.Cardiologist on the way.Reminded them they could not pull catheter through sheath for fear of shearing balloon but rather balloon should be pulled back to the sheath and pulled as one piece.Catheter removed and was disposed of.Patient was stable without the balloon there was no reported injury or adverse event to the patient.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
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Search Alerts/Recalls
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