|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Death (1802)
|
Event Date 12/31/2017 |
Event Type
Death
|
Manufacturer Narrative
|
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.To date, the customer has not provided the details of the involved pump.However, the customer has confirmed that the patient did not die from iabp failure, but that she did pass away from another complication several days following surgery.If additional information is provided, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that on (b)(6) 2017, patient was transferred from (b)(6)facility with an unknown getinge intra-aortic balloon pump (iabp) in use, and the intra-aortic balloon (iab) was in situ.On (b)(6) 2017, the perfusionist was called by the bedside nurse who noticed frank blood present in the gas line.The perfusionist advised the registered nurse to put the iabp on standby, and the cvt was informed.The patient was then taken to the operating room (or) and the defective iab was removed without difficulty and a new iab was reinserted.It was reported that the patient later died, but the date of the death is unknown.The death is not attributed to the iabp.A separate report will be submitted for the involved iab.
|
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Getinge service was not requested.However, the customer advised that no evaluation was performed, there was no failure of the iabp, and that it was used on the same patient post-op with no issues.The patient died several days later, and the iabp remains in clinical service.(b)(4).
|
|
Event Description
|
It was reported that on (b)(6) 2017, patient was transferred from windsor to lhsc facility with the cs300 intra-aortic balloon pump (iabp) in use, and the intra-aortic balloon (iab) was in situ.On (b)(6) 2017, the perfusionist was called by the bedside nurse who noticed frank blood present in the gas line.The perfusionist advised the registered nurse to put the iabp on standby, and the cvt was informed.The patient was then taken to the operating room (or) and the defective iab was removed without difficulty and a new iab was reinserted.It was reported that the patient later died, but the date of the death is unknown.The death is not attributed to the iabp.A separate report will be submitted for the involved iab.
|
|
Search Alerts/Recalls
|
|
|