BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 19665781 · Received July 3, 2024

    Report

    Report Number
    1416980-2024-03367
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 8, 2024
    Report Date
    August 5, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412030531
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER POSTAL CODE: (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.

    Additional Manufacturer Narrative · 0

    B5: REMOVE THE SENTENCE: ¿THE EVENT WAS FURTHER DESCRIBED AS ¿LEAKING FROM INSIDE HIT WAS REPORTED THAT A HOMECHOICE (HC) CASSETTE LEAKED.¿ (DUPLICATED INFORMATION). G4: 510K #: REMOVE NI (REPORTED ON INITIAL REPORT) AND REPLACE WITH K102936. H11: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED. THE EVENT WAS FURTHER DESCRIBED AS ¿LEAKING FROM INSIDE HIT WAS REPORTED THAT A HOMECHOICE (HC) CASSETTE LEAKED. THE EVENT WAS FURTHER DESCRIBED AS ¿LEAKING FROM INSIDE HC'S CENTER, DRIPPING FROM THE BOLT BESIDE A METAL PLAQUE BELOW HC¿. THE PATIENT NOTED A PUDDLE BELOW THE HC DEVICE. THIS WAS OBSERVED DURING SET UP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. RENAL THERAPY SERVICES (RTS) DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WITH THE PATIENT. 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
    801265 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA S24C06008 00085412030531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male HOMECHOICE CLARIA