DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number UNKNOWN |
Device Problems
Leak/Splash (1354); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/27/2022 |
Event Type
Injury
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy blood was seen in the inner lumen line running to the flush bag.The customer proceeded to flush the line for a few minutes until it cleared.Directly after that, the patient developed some chest tightness and shortness of breath for a period of about 10 minutes.The customer wanted to know what it may mean clinically and if the iab may need to be removed from the patient.The getinge representative asked if the pump was put in standby, as per the ifu during flushing.The customer stated that they had not put the pump in standby.The getinge representative reviewed the importance of performing flushing while in standby and the possible clinical results if not followed correctly.The customer then stated that the patient seem clinically stable and therapy was being delivered as expected.The customer ordered a chest x-ray which indicated that the iab was not in the proper position.It was later reported that the patient was stable.
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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.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Search Alerts/Recalls
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