MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C8302C
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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 use of the homechoice cassette during peritoneal dialysis therapy.During the troubleshooting, it was reported that the drainage line separated from the homechoice cassette causing a leak which led to the alarm.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
One actual sample was received for evaluation.A visual inspection with the naked eye was performed on the actual sample with no issues noted.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted; the drainage (patient) line was intact during testing.The reported condition was not verified during actual sample testing.However, a photograph of the cassette was provided revealing that the patient line was separated from the cassette which would have resulted in the alarm.The reported condition was verified during photographic inspection.The cause of the patient line separation was related to a manufacturing issue.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.

• Brand Name: HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9252793
• Report Number: 1416980-2019-05986
• Device Sequence Number: 2171741
• Product Code: FKX
• UDI-Device Identifier: 00085412087405
• UDI-Public: (01)00085412087405
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K012988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/11/2024
• Device Catalogue Number: 5C8302C
• Device Lot Number: H19B11051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1