Catalog Number 0684-00-0605 |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2024 |
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 the day after inserting the intra-aortic balloon (iab), the doctor was informed that the console had stopped and indicated a fiber optic sensor failure.No alarm record was noted in the log.When the doctor went to check, the console was working as expected.They believe the pressure readings may not have been displayed.The iab was removed after two days of therapy.There was no patient harm or adverse event reported.
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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 not a maquet product.The extender tubing was also returned.A kink was found on the catheter tubing and inner lumen approximately 76.5cm from the iab tip.The optical fiber was found to be broken within the membrane approximately 23.9cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was able to be cleared.The optical fiber was found to be broken, confirming the reported problem.We are unable to determine when this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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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