BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3123229 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13098
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK FROM THE HEATER BAG WHILE USING AN AUTOMATED PERITONEAL DIALYSIS WITH CASSETTE ON A HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) ATTACHED THE HEATER BAG TO THE SET INCORRECTLY AND IT STARTED TO LEAK. THE HP DISCONNECTED WHEN THE LEAK WAS NOTICED. THERE WERE NO ALARMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224059 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR UNKNOWN PERITONEAL DIALYSIS SOLUTION| HOMECHOICE