BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 20065409 · Received August 26, 2024

    Report

    Report Number
    1416980-2024-04496
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 24, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D2A AND D2B: D2A: COMMON DEVICE NAME: REMOVE: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE AND REPLACE WITH: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY. D2B: CLASSIFICATION CODE: REMOVE: KDJ AND REPLACE WITH: FKX. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOMECHOICE PERITONEAL DIALYSIS (PD) CASSETTE SET LEAKED. IT WAS FURTHER DESCRIBED AS "FLUID LEAKAGE ON OCCLUDE". THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481891 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CLARIA| UNSPECIFIED PD SOLUTION BAG