MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. LOW RECIRCULATION VOLUME APD SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	N5C8305C
Medical Device Problem Codes	Fluid/Blood Leak (1250); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 dwell eight of ten of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a leak between the supply line of the homechoice cassette and the supply bag that led to this alarm.The leak was further described as "when closing the clamps, caregiver (cg) noticed some wetness at the connection of one of the supply bags and the supply line, cg did not notice any visible damage".Renal therapy services (rts) assisted the cg to close the transfer set and disconnect the patient using the aseptic way.Rts reviewed proper procedures per the user manual with the cg.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6 and h11.H11: 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.

• 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: 19992457
• Report Number: 1416980-2024-04302
• Device Sequence Number: 7057674
• Product Code: FKX
• UDI-Device Identifier: 00085412087672
• UDI-Public: (01)00085412087672(10)H24C29062(17)290329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: Lay User/Patient
• Device Model Number: N5C8305C
• Device Catalogue Number: N5C8305C
• Device Lot Number: H24C29062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2024
• 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: HOMECHOICE CLARIA; UNSPECIFIED PD SOLUTION BAG
• Patient Sex: Unknown