BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1883606 · Received October 26, 2010

    Report

    Report Number
    1423500-2010-04950
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 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). THE SAMPLE WAS DISCARDED. 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 AIR IN THE PATIENT LINE. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION 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

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING AIR IN THE PATIENT LINE THAT OCCURRED ON THE HOME CHOICE (HC) UNIT AT CONNECT YOURSELF/CHECK PATIENT LINE. THE HP STATED SHE CHECKED THE PATIENT LINE PRIOR TO CONNECTING AND THOUGHT THE FLUID WAS TO THE TOP; SHE CONNECTED AND THEN REALIZED THAT THERE WAS AIR IN THE LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP WOULD BE UNABLE TO DO A REPRIME AT THIS POINT SINCE SHE WAS CONNECTED TO THE MACHINE. THE TSR ADVISED THE HP TO CLOSE ALL CLAMPS AND CYCLE POWER THEN EXPLAINED THAT THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HP UNDERSTOOD AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR