BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2842754 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05755
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED; PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT CHANGED THE SOLUTION BAGS DURING THERAPY. THE HOME PATIENT STATED SHE KNEW HOW THE AIR GOT IN; SHE HAD CONNECTED THE BAGS, AND THEN REALIZED SHE CONNECTED A BAG TO THE WRONG LINE SO SHE DISCONNECTED THE LINE AND CONNECTED IT TO ANOTHER BAG. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT CONDUCTED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN LINE) DURING THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) THAT AIR HAD ENTERED THE SETUP. THE HP STATED SHE KNEW HOW THE AIR GOT IN, SHE HAD CONNECTED THE BAGS, THEN REALIZED SHE CONNECTED A BAG TO THE WRONG LINE SO SHE DISCONNECTED THE LINE AND CONNECTED IT TO ANOTHER BAG. THE HP STATED SHE KNEW SHE SHOULD NOT HAVE DONE THIS. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE TSR HAD THE HP CLOSE ALL THE CLAMPS, TRANSFER SET AND RECYCLE THE POWER AND THE SYSTEM ERROR 2367 ALARMED. THE TSR INSTRUCTED THE HP TO RECYCLE THE POWER AGAIN TO PRESS GO TO START. THE HP WOULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE