Catalog Number 0684-00-0605 |
Device Problems
Failure to Calibrate (2440); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Event site postal code: (b)(6).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 inserting the intra-aortic balloon (iab) and connecting it to the console, the console indicated that there was an optical sensor calibration issue.It was also reported that the blood pressure was not displayed.The console was still able to pump so therapy was continued.The iab was later removed.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.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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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.A kink was found on the catheter tubing approximately 35.1cm from the iab tip.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and a break was observed within the y-fitting.The optical fiber was found to be broken, confirming the reported problems.We are unable to determine when this may have occurred.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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 may-19 to apr-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).
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Search Alerts/Recalls
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