MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. LOW RECIRCULATION VOLUME APD SET; 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	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter telephone extention: ext.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the cap was disconnected from the patient line of a homechoice low recirculation volume apd set with cassette; this was described as ¿when the package was opened, the cap of the tube was not connected¿.This was observed before use of the device for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and the clear pull ring cap was observed off the patient connector.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.

• Brand Name: LOW RECIRCULATION VOLUME APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 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: 20452300
• Report Number: 1416980-2024-05769
• Device Sequence Number: 20956665
• Product Code: FKX
• UDI-Device Identifier: 00085412087405
• UDI-Public: (01)00085412087405(10)H23A17021(17)280117
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: Health Professional
• Device Catalogue Number: 5C8302C
• Device Lot Number: H23A17021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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
• Patient Sex: Unknown