MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the event occurred on an unknown date in (b)(6) 2025.E1: initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a connection issue between the low recirculation volume apd set and minicap transfer set.The patient woke up disconnected.This was further described as ¿the cassette did not 'lock' and kept rotating, as if there was a problem with the thread, appearing worn out¿.Adhesive tape was applied to prevent it from coming loose.This occurred during use of the devices for automated peritoneal dialysis (apd) therapy.There was no report of patient injury or medical intervention associated with this event, however, the patient was given antibiotics prophylactically.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6 and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was reviewed and showed the patient connector not fully flushed to the female connector; however, due to a photo only evaluation and not receiving the actual sample for testing, the sample analysis was unable to confirm nor refute the report of connection 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: LOW RECIRCULATION VOLUME APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 21739048
• Report Number: 2314912-2025-00184
• Device Sequence Number: 11767784
• Product Code: FKX
• UDI-Device Identifier: 00085412087405
• UDI-Public: (01)00085412087405(10)H23K12022(17)281112
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K012988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Catalogue Number: 5C8302C
• Device Lot Number: H23K12022
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFER SET
• Patient Sex: Unknown