BAXTER HEALTHCARE CORPORATION HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
|
Back to Search Results |
|
Catalog Number L5C4531 |
Device Problems
Improper Flow or Infusion (2954); Protective Measures Problem (3015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/28/2023 |
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 an unspecified cycle of peritoneal dialysis (pd) therapy.During the troubleshooting, it was reported that the ¿supply bag was swollen with air¿ during use of a homechoice cassette which led to the alarm.Renal therapy services advised the patient to contact their nurse regarding the issue.Proper procedures per the user manual were reviewed with the patient.The patient had manual supplies to continue therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
H10: an alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned; therefore, a device analysis could not be completed.However, it was reported that the ¿supply bag was swollen with air¿ during use of a homechoice cassette, which is known to cause this alarm.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|