Model Number 0684-00-0296-01 |
Device Problems
Difficult to Flush (1251); Material Deformation (2976); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.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 waveform was dampened.The customer replaced the iab, but the same issue occurred.The customer was advised to re-zero and flush the iab.It was reported that both iabs were very difficult to flush.It was noted that there was a possibility of a severe kink which was causing the difficulty to flush.The customer was advised to try a different pressure cable and transducer.They were also notified that they could obtain a separate arterial line on the patient and attempt to transduce it to the console.There was no patient harm or adverse event reported.This report is for the first iab used in this event.A separate report will be submitted for the second iab used.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A kink was found on the inner lumen and catheter tubing near the y-fitting approximately 76.5cm from the iab tip.The technician attempted to aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was kinked and occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.The condition of the iab as received indicated an occlusion and a kink in the inner lumen and catheter tubing.We are unable to determine how this may have occurred.The evaluation confirmed the reported problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall complaint trend data for the period may-19 to apr-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Search Alerts/Recalls
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