BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1792099 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02342
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 18, 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). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED AS A SAMPLE OR BATCH DETAILS WERE NOT AVAILABLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, NOT ENOUGH DATA IS AVAILABLE WITHIN THE REPORT TO IDENTIFY ROOT CAUSE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE HOME PATIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM AND SE 2367 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 3 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE TSR THEN INSTRUCTED THE HP TO START OVER WITH NEW SUPPLIES OR FINISH WITH MANUAL SUPPLIES. THE HP STATED THAT SHE JUST WANTED TO END THERAPY SINCE SHE WAS ALMOST FINISHED ANYWAY. THE TSR ADVISED THE HP TO INFORM THE NURSE (RN) WITHIN THE NEXT 24 HOURS OF THE ALARM AND ANY MISSED THERAPY. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S RN. THE RN STATED THAT THE PATIENT WAS SEEN RECENTLY AND WAS DOING FINE WITH THERAPY. THE NURSE STATED THE HOME PATIENT HAD NOT REPORTED ANY ALARMS/ISSUES WITH THERAPY. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR