BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1630653 · Received March 15, 2010

    Report

    Report Number
    1423500-2010-00241
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN. IF A SAMPLE BECOMES AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT HAVING A CHECK SUPPLY LINE ALARM WITH THE HOMECHOICE (HC) MACHINE DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO PUSH AND TURN THE SPIKE ON THE SUPPLY LINE, MOVE THE WHITE CLAMP DOWN THE LINE AND RESTART PRIME. THE HP STATED THE SOLUTION WAS NOT MOVING THROUGH THE LINE. THE TSR HAD THE HP TURN THE SUPPLY BAG OVER. THE HP STATED THE SPIKE CAME OUT. THE TSR HAD THE HP PRESS STOP AND INSTRUCTED THE HP TO DISCARD THE SUPPLY AND GET A NEW BAG. THE HP HAD AN UNUSED SUPPLY LINE. THE TSR HAD THE HP CONNECT THE NEW BAG TO THE UNUSED SUPPLY LINE AND CLOSE THE CLAMP ON THE USED SUPPLY LINE. PRIME RESTARTED. THE HC PRIMED NORMALLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR