BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1821266 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03021
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 7, 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). THIS COMPLAINT FOR SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 3 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE WAS FIRED, THE MIDDLE OF THE STAPLE LINE BLEED. THE EVENT OCCURRED WITH THREE FIRINGS. THEY USED BOVIE TO CORRECT THE BLEEDING. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 3 OF 5 ON THE HOMECHOICE(HC). THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED ANY TIME PRIOR TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ALARM AND HAD HP CYCLE POWER TO CLEAR. TSR EXPLAINED HP WOULD NEED TO START OVER WITH NEW SUPPLIES. HP STATED THAT HE JUST WANTED TO END THERAPY FOR THE NIGHT. TSR ADVISED HP TO CALL REGISTERED NURSE IN THE NEXT 24 HOURS AND INFORM HER OF THE ALARM AND ANY MISSED THERAPY. HP UNDERSTOOD EXPLANATIONS, AND WILL CALL RN. CAUSE OF THE ALARM WAS UNDETERMINED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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