|
Catalog Number 2C1155KP |
Device Problem
Filling Problem (1233)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
malfunction
|
Event Description
|
It was reported that a large volume multirate infusor overinfused.The patient received its contents over approximately 48 hours instead of over 96 hours.The device was filled with fluorouracil.This was discovered during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
E1: initial reporter address: (b)(6).E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
H4: device manufacture date - the lot was manufactured between september 16-17, 2022.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|