BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3001048 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-05852
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) AND IT WAS REPORTED THAT THE SUPPLY BAG BECAME DISCONNECTED. LINE DISCONNECTION DURING THERAPY IS A KNOWN CAUSE OF SYSTEM ERROR 2240.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) ON THE HOME CHOICE (HC) DURING PERITONEAL DIALYSIS, DWELL 4. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE SE. THE HP STATED THAT SHE GOT THE SE AND NOTICED THAT THE SUPPLY BAG WAS DISCONNECTED. THE HP DISCONNECTED THEMSELVES AND CALLED GTS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED HOW TO CLEAR THE SES AND THAT THE SUPPLIES WERE COMPROMISED. THE HP WOULD FINISH MANUALLY. THE TSR ADVISED THE HP TO CALL THE REGISTERED NURSE (RN) IN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAPPENED. THE HP UNDERSTOOD THE EXPLANATIONS, WOULD GO CLEAR THE ALARMS, FINISH MANUALLY, AND CALL THE RN. THERE WAS PATIENT INVOLVEMENT BUT 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
    105537 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE