Catalog Number ASKU |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/06/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned and the lot number is unknown; 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 a homechoice cassette leaked due to a hole in the cassette.This occurred during fill one of four of peritoneal dialysis therapy.Renal therapy services (rts) assisted the patient in starting over with new supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
Corrected information : it was reported that a homechoice cassette leaked due to a hole in the patient line (previously incorrectly reported as a hole in the cassette).Further described by the patient as ¿when the device started the fill cycle, the patient line started to leak and they noticed a hole in the line¿.The patient was connected at the time of the event (omitted on initial).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|