Catalog Number 0684-00-0475 |
Device Problems
Material Rupture (1546); Device Displays Incorrect Message (2591)
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Patient Problem
No Code Available (3191)
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Event Date 03/11/2018 |
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.(b)(4).
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Event Description
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It was reported that a post operation liver transplant patient was on day four of intra-aortic balloon (iab) therapy and frank blood was noted in the gas line and the console alarmed "gas leak".The customer stated the iab was advanced the night before as per last cxr (chest x-ray) but no new x-ray was done to confirm placement.Balloon was removed and not replaced.Balloon gas line was inflated after removal with saline and balloon was patent with no leaks.The customer thought the inner gas line/pressure transducer line ruptured.Patient was stable without iab, on crrt (continuous renal replacement therapy) and awaiting re-do liver transplant.Patient was on intubated and on ventilator but was hemodynamically stable and did not require replacement of iab catheter.The indication for use was cardiogenic shock.There were no injuries reported to the patient.
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Event Description
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It was reported that a post operation liver transplant patient was on day four of intra-aortic balloon (iab) therapy and frank blood was noted in the gas line and the console alarmed "gas leak".The customer stated the iab was advanced the night before as per last cxr (chest x-ray) but no new x-ray was done to confirm placement.Balloon was removed and not replaced.Balloon gas line was inflated after removal with saline and balloon was patent with no leaks.The customer thought the inner gas line/pressure transducer line ruptured.Patient was stable without iab, on crrt (continuous renal replacement therapy) and awaiting re-do liver transplant.Patient was on intubated and on ventilator but was hemodynamically stable and did not require replacement of iab catheter.The indication for use was cardiogenic shock.There were no injuries reported to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The pressure tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and one leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.076cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.The evaluation confirmed the reported problem.An abrasion leak is a known inherent risk and common failure mode caused by calcified plaque in the aorta.We are unable to confirm the reported iab migration because we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
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Search Alerts/Recalls
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