DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number UNKNOWN |
Device Problems
Inability to Auto-Fill (1044); Off-Label Use (1494); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Complete event site name: (b)(6) hospital.Complete initial reporter name: (b)(6).Occupation: administrator/ supervisor.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 record id # (b)(4).
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Event Description
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It was reported that after weeks of intra-aortic balloon (iab) therapy on a pre-transplant patient, the console generated gas loss and autofill failure alarms.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer swapped out the console for a different one, but the same issue occurred.The patient was taken for iab repositioning/ replacement.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-2019 through aug-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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