BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1904473 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06079
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 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 AND THE LOT NUMBER WAS NOT KNOWN, THEREFORE NO DEVICE EVALUATION OR BATCH REVIEW CAN BE PERFORMED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOR A CONNECTION ISSUE - DISCONNECTION OF A SUPPLY BAG. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF CASSETTE SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. CAREGIVER DID NOT START OVER WITH NEW SUPPLIES AS INSTRUCTED BY THE BAXTER REPRESENTATIVE AND RECEIVED A SYSTEM ERROR 2005. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT 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 CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A DISCONNECTION OF THE FINAL BAG THAT OCCURRED ON THE HOME CHOICE UNIT AT FILL. THE CG STATED THE FINAL BAG HAD DISCONNECTED AND SHE CLAMPED OFF THE FINAL BAG AND CHANGED THE PROGRAMMING TO DO ONLY A THIRD OF THE THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE CG CONTINUED TO FILL THE HOME PATIENT (HP), AND THEN THE CG STATED SHE GOT A SYSTEM ERROR (SE) 2005 SO SHE CYCLED POWER AND CONTINUED WITH THERAPY. THE TSR ADVISED AGAIN TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE CG CONTINUED TO FILL THE HP AND STATED IF THE SE REPEATED SHE WOULD END THERAPY AND START OVER WITH NEW SUPPLIES, OTHERWISE SHE WOULD CONTINUE WITH THERAPY. 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 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR