BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1760341 · Received July 18, 2010

    Report

    Report Number
    1423500-2010-01527
    Event Type
    Malfunction
    Date Received
    July 18, 2010
    Date of Event
    June 27, 2010
    Report Date
    June 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK HEATER LINE ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING FILL 1 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO PUSH IN SPIKE AND TURN LEFT AND RIGHT ON THE HEATER BAG. THE HP STATED THE HC ALARMED AGAIN. THE TSR ADVISED THE HP TO CHECK THE PATIENT LINE FOR FIBRIN. THE HP STATED THERE WAS NO FIBRIN BUT HE FOUND AIR IN THE PATIENT LINE. THE HP STATED THAT HE PICKED UP THE HEATER BAG AND AIR WAS REPLACED WITH FLUID. THE TSR ASKED THE HP TO PULL UP AND DOWN SEVERAL TIMES AND PRESS GO. THE HP STATED THE HC THEN ADVANCED TO FILL 1 OF 5. THE HP CONFIRMED HE WAS ABLE TO COMPLETE FILL VOLUME OF 2000 ML. THE HP CONFIRMED HE FELT FINE. ON (B)(6) 2010 (B)(4) SPOKE WITH THE HOME PATIENT (HP) WHO STATED HE HAS HAD NO ADVERSE EFFECTS FROM THIS INCIDENT. THE HP STATED HE WAS DOING FINE WITH THERAPY AND DID NOT NOTICE ANYTHING UNUSUAL ABOUT HIS SUPPLIES. THE HP CONFIRMED HE USES A COMPACT EXCHANGE DEVICE (CXD) TO ASSIST HIM WITH SPIKING BAGS AND HAS HAD NO PROBLEMS WITH IT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 65 YR