Model Number IPN000254 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
|
Patient Problem
Death (1802)
|
Event Date 08/10/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) was showing alarms (helium loss, leakage of helium, and kinked catheter).The end user stopped the iabp pumping and removed the intra-aortic balloon (iab).Once the iab was removed the staff found the membrane ruptured and "black dots" inside the membrane.There was a patient death.Dr.(b)(6) made the medical judgement that the device did not cause or contribute to the patient's death.
|
|
Event Description
|
It was reported that the intra-aortic balloon pump (iabp) was showing alarms (helium loss, leakage of helium, and kinked catheter).The end user stopped the iabp pumping and removed the intra-aortic balloon (iab).Once the iab was removed the staff found the membrane ruptured and "black dots" inside the membrane.There was a patient death.Dr.Amal a louis made the medical judgement that the device did not cause or contribute to the patient's death.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter which allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
|
|
Search Alerts/Recalls
|