Catalog Number R5C4479 |
Device Problems
Leak/Splash (1354); Device Displays Incorrect Message (2591)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during a dwell phase of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a leak in the supplies.The patient was not able to identify the exact location of the leak.The patient started over with new supplies.Renal therapy services (rts) referred the patient to the hospital to complete therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
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
|