Catalog Number IAB-05830-LWS |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 12/28/2015 |
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 was reported that the rn called and stated that they had a female patient (pt) with a 30cc fiberoptix intra-aortic balloon (iab) that was inserted around midnight on (b)(6) 2015.Indication for use: three vessel disease.The iab was removed because they had two "high pressure" alarms and could not figure out what the problem was.They also noted that there was blood backing up in the transducer tubing of the central lumen.The rn stated that the pt was not moving or coughing, was in a sinus rhythm and did not have any pressors infusing.They had straightened the tubing and tried to flush the central lumen.The clinical support specialist (css) explained that the blood backing up in the transducer tubing was unrelated to the high pressure alarms, which was related to the gas going in and out of the balloon.The css explained that they might have tried to decrease the balloon volume for the high pressure alarm and checked the position of the balloon on x-ray.Since there was blood backing up in the central lumen, the css said she would have had them check the transducer set-up as there may have been a crack in the stopcock.The pt was stable without intra-aortic balloon pump (iabp) therapy and waiting to be evaluated for cabg (coronary artery bypass graft) surgery.
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Manufacturer Narrative
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(b)(4).Device evaluation: returned for evaluation was a 30cc 8.0fr iab fos.The central lumen was noted heavily kinked within the returned packaging.The bladder membrane was wrapped in bubble wrap and the entirety of the iab was held by a rubber band.After removing the rubber band it appeared the central lumen broke, as the iab unraveled out of the position it was returned in.It is possible the central lumen was already broken previously.The breaking point of the central lumen was located approximately 17.0cm from the luer end of the catheter.The fiber was also found broken in this location.The fiber was intact at the tip of the catheter.The one-way valve was not returned with the iab.Blood was noted within the bladder membrane.The fos connector and cal key were examined.The gray fos connecter was properly seated 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.See other remarks section for continuation.Other remarks: the cal key and fos were connected to the iabp.The cal key was recognized.The pump status was ll pl.The fiber was previously noted broken approximately 17.0cm from the luer end of the catheter.The fiber was intact at the tip of the catheter.The iab was submerged in water and leak tested.The catheter was found leaking through the distal tip of the catheter because of the broken central lumen; however, no holes or leaks were detected on the bladder membrane.The bladder membrane passed functional testing.The iab failed leak test.A device history record 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 high pressure alarms is not able to be confirmed.The iab could not be pump tested because of the condition it was returned in.Blood was found within the iab upon return; however, the event details did not make any note of this issue.The blood likely entered the iab as a result of the broken central lumen.The root cause of the broken central lumen is undetermined.
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Event Description
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It was reported that the rn called and stated that they had a female patient (pt) with a 30cc fiberoptix intra-aortic balloon (iab) that was inserted around midnight on (b)(6) 2015.Indication for use: three vessel disease.The iab was removed because they had two "high pressure" alarms and could not figure out what the problem was.They also noted that there was blood backing up in the transducer tubing of the central lumen.The rn stated that the pt was not moving or coughing, was in a sinus rhythm and did not have any pressors infusing.They had straightened the tubing and tried to flush the central lumen.The clinical support specialist (css) explained that the blood backing up in the transducer tubing was unrelated to the high pressure alarms, which was related to the gas going in and out of the balloon.The css explained that they might have tried to decrease the balloon volume for the high pressure alarm and checked the position of the balloon on x-ray.Since there was blood backing up in the central lumen, the css said she would have had them check the transducer set-up as there may have been a crack in the stopcock.The pt was stable without intra-aortic balloon pump (iabp) therapy and waiting to be evaluated for cabg (coronary artery bypass graft) surgery.
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Search Alerts/Recalls
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