Catalog Number L5C4531 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the patient line connector of a homechoice cassette separated from the patient line and resulted in a leak.This occurred during dwell four of five of peritoneal dialysis therapy.The home patient (hp) was connected at the time of the event.The hp stated that ¿when they took out the pull ring cap from the patient line during set up, the patient line connector came off¿.The hp connected the patient line connector back on by taping it and continued with the therapy.The patient woke up and noticed that the solution leaked out of the patient line.Renal therapy services (rts) assisted the patient in ending therapy and advised the hp to contact their nurse for further assistance.There was no patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
Additional information : 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
|