BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGRATED APD SET

    MDR report key: 21774066 · Received April 4, 2025

    Report

    Report Number
    2314912-2025-00207
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 9, 2025
    Report Date
    May 8, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4: WEIGHT: 68 (UNIT NOT SPECIFIED). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: UPDATE THE PRODUCT TO A HOMECHOICE AUTOMATED PD SET WITH CASSETTE (PREVIOUSLY REPORTED AS AN EXTENSION SET). D1: INTERGRATED APD SET (REMOVE: EXTENSION SET WITH EASY-LOCK CONNECTOR) D2A: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY (REMOVE: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE D2B: FKX (REMOVE KDJ) D4: CATALOGUE # L5C4531 (REMOVE 5C4480C) D4: LOT #: REMOVE: H24J01091 AND REPLACE WITH NI D4: UDI #: (B)(4): THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. (REMOVE: (B)(4). D10: CONCOMITANT PRODUCT: REPLACE NI WITH EXTENSION SET G1: REMOVE NAME AND ADDRESS FOR VANTIVE HEALTHCARE MOUNTAIN HOME AND REPLACE WITH VANTIVE HEALTHCARE CORPORATION AND NI FOR ADDRESS LOCATION. G1: DEVICE MANUFACTURER COUNTRY: REMOVE UNITED STATES AND REPLACE WITH NI G4: G4: K102936 (REMOVE K925403) H4: REPLACE 10/01/2024 WITH NI H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND A CUT ON THE PATIENT LINE TUBING WAS OBSERVED. LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED, LEAKS FROM THE CUT IN THE PATIENT LINE TUBING WAS CONFIRMED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSTON SET HAD A HOLE AND A SLIT WHICH RESULTED IN A LEAK. THE PATIENT NOTICED THERE WAS FLUID ON THE FLOOR. THIS OCCURRED DURING THE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. A CUTTER OR KNIFE WAS NOT USED TO OPEN THE BOX. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT; HOWEVER THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262749 INTERGRATED APD SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX VANTIVE US HEALTHCARE LLC NA H24J01091

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female EXTENSION SET.| NI.