It was reported that after a couple days of intra-aortic balloon (iab) therapy, the console was generating an iab catheter restriction alarm as the patient was brought to the operating room for a left ventricular assist device (lvad) placement.The surgeon commented that they would remove the iab the following morning.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 and advised they would continue to troubleshoot as if it were a femoral insertion.At this point, the console had been in stand-by mode for 22 minutes.After some quick discussion of troubleshooting, the customer was able to restart the therapy.The customer stated that they had repositioned the patient to relieve the kink.They verbalized that there was no visual blood, no kinks, no condensation in the helium tubing, and all connections were secure.There was no patient harm, or adverse event reported.
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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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