Catalog Number IN2C1155KP |
Device Problem
Filling Problem (1233)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The devices were discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that four (4) infusors underinfused during patient infusion.It was further reported that the expected therapy time was 46 hours.The reporter stated that after 48 hours, drug remained in the device.The device was filled with fluorouracil.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The device was manufactured from june 27, 2018 - june 28, 2018.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
|