Catalog Number IAB-05840-LWS |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Atherosclerosis (1728)
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Event Date 05/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It has been reported that the event involved a 160cm in height.While in open heart surgery the iab was inserted via the patients "ascending aorta." after ~10-15 min of counter-pulsation was initiated and during weaning of bypass the autocat2 console alarmed "helium loss." the md and perfusionist found blood in the helium tubing immediately and the pump was switched off and the iab was removed and replaced successfully.There was a 5 minute delay in iabp therapy.The patient expired 7 hours later.The md and perfusionist stated that the patient was extremely ill and the iab did not contribute to the patient's death.
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Manufacturer Narrative
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(b)(4).Returned for evaluation was a 40cc 8.0fr fos iab with the supplied return kit.The bladder membrane and bifurcate were wrapped in bubble wrap.Blood was noted within the bladder membrane and short driveline tubing.The short driveline tubing was cut at the bifurcate.The one-way valve was not returned with the device.No kinks or bends were noted to the central lumen upon return.The fos connector and cal key were examined.The gray fos connecter was found recessed in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined and no abnormalities were noted.The cal key was intact.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The fos and cal key were connected to the iabp.The pump displayed an "eo" status indicating a potentially dirty fos connector.After cleaning the tip with isopropyl alcohol, the fos was tested again, and the fos status was "ok".See other remarks section.Other remarks: the iab was submerged in water and leak tested using the mdt-50.A leak was found approximately 37.5cm from the distal tip on the outer lumen of the device.Under microscopic inspection, a puncture consistent with contact from a sharp object was found on the outer lumen.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is confirmed.A puncture consistent with contact from a sharp object was found on the outer lumen which likely allowed blood to enter the helium pathway.The root cause of the damage is undetermined.
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Event Description
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It has been reported that the event involved a (b)(6) cm in height.While in open heart surgery the iab was inserted via the patients "ascending aorta." after approximately 10-15 min of counter-pulsation was initiated and during weaning of bypass the autocat2 console alarmed "helium loss." the md and perfusionist found blood in the helium tubing immediately and the pump was switched off and the iab was removed and replaced successfully.There was a 5 minute delay in iabp therapy.The patient expired 7 hours later.The md and perfusionist stated that the patient was extremely ill and the iab did not contribute to the patient's death.
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Search Alerts/Recalls
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