DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Catalog Number 0684-00-0475 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2024 |
Event Type
malfunction
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Event Description
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It was reported that after 20 hours of intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm and the augmentation could not be obtained.It was noted that a flush system was connected.The iab was removed after 23 hours of therapy.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Complete event site name: (b)(6).Event site postal code: (b)(6).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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N/a.
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Manufacturer Narrative
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Photographs were provided by the facility.The photograph shows the iab with the membrane completely unfolded and blood on the interior and exterior of the catheter tubing and membrane.A video was also provided which shows the pump alarming "check iab catheter".No decon or visual inspection performed since product was not returned and could not be evaluated.Based on the video and photographic evidence provided by the facility, the reported failures "alarm, check iab catheter" & "difficult/ unable to monitor pressure (augmentation)" are confirmed due to a leak.However, since the product was not returned, we were unable to evaluate the device.Therefore, we are unable to determine a root cause.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).
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Manufacturer Narrative
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**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).Complaint record id # (b)(4).
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Event Description
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N/a.
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