BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1854556 · Received October 5, 2010

    Report

    Report Number
    1423500-2010-04064
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CONNECTION ISSUE. 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 ISSUE WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SPIKE THAT DISCONNECTED FROM THE HEATER BAG ON THE HOMECHOICE (HC) MACHINE DURING USE. THE HP STATED, HE WAS NOT CONNECTED. THE HP STATED THAT WHILE CONNECTING THE HEATER BAG WITH THE COMPACT EXCHANGE DEVICE, THE SPIKE CAME OUT OF THE BAG. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT IF THE SPIKE COMES OUT AFTER THE SEAL ON THE BAG HAS BEEN BROKEN, THE HP SHOULD START OVER WITH A NEW BAG AND NEW CASSETTE,. THE HP UNDERSTOOD EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR