BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3770643 · Received April 24, 2014

    Report

    Report Number
    1416980-2014-13203
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION BETWEEN A HOMECHOICE (HC) CASSETTE AND THE HEATER BAG LEAKED SOLUTION. THE HOME PATIENT (HP) NOTICED SOLUTION ON THE FLOOR THE MORNING AFTER THERAPY AND DISCOVERED THE LEAK. THE HP INDICATED THAT THE THREADS OF THE CONNECTION PIECES WERE STRIPPED FROM ¿OVER TIGHTENING.¿ A TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO INFORM A NURSE ABOUT THE ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249741 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE