Model Number 0684-00-0576-01 |
Device Problems
Off-Label Use (1494); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2021 |
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 after several days of intra-aortic balloon (iab) therapy, the fiber optic sensor stopped being able to calibrate.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 nature of axillary insertions and calibration requirements not being met.The customer was then assisted in getting the transducer system set up and attempted to aspirate the fluid lumen clean without success.The need for an alternate arterial source was noted.The customer will request a radial or balloon reposition/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-19 through aug-21 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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Event Description
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N/a.
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Manufacturer Narrative
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Additional information: type of investigation code - added 4115, device available for eval changed from yes to no 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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Search Alerts/Recalls
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