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 Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient line cap (pull ring) of six (6) homechoice low recirculation volume apd set with cassettes had come loose while in the packaging.This was observed before use of the devices for peritoneal dialysis (pd) therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The actual devices were not available; however two (2) photographs of the sample were provided for evaluation.The photographs were visually inspected and the patient connectors on two samples were without a clear pull ring cap.The clear cap was loose inside the over pouch on one set; however, due to a photo only evaluation, the sample analysis was unable to determine if the other caps were loose inside the over pouch.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: three (3) samples were received for evaluation.A visual inspection with the naked eye noted one sample had a loose clear cap to the patient connector inside one closed pouch and two samples in open pouches were not positioned on the patient connectors or loose inside the open pouches.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information /correction h10: three actual samples were received for evaluation; the other three (3) samples were not received and therefore could not be evaluated.Correction: two (2) of the three samples were received in open pouches and the clear caps of these (2) samples were not positioned on the patient connectors.Remove statement: ¿or loose inside the open pouches¿ as previously reported.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
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17682905
• Report Number: 1416980-2023-04454
• Device Sequence Number: 6246723
• Product Code: FKX
• UDI-Device Identifier: 00085412087405
• UDI-Public: (01)00085412087405
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K012988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/30/2024

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 Catalogue Number: 5C8302C
• Device Lot Number: H22F10026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 11/02/2023; 01/30/2024; 01/30/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/20/2023; 11/22/2023; 01/30/2024; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown