Model Number 0684-00-0478-01 |
Device Problems
Off-Label Use (1494); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/17/2021 |
Event Type
malfunction
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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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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the customer was changing the flush line tubing per their protocol when the stopcock broke.This resulted in the line clotting off as the problem was not remedied quickly.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was made aware of the off-label use.The customer was then notified of the need for the arterial pressure waveform on the console and the many options of how to obtain it.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Device available for eval changed to no.Additional reporter name: (b)(6).Additional email: (b)(6).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 jun-2019 through jul-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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