BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1992219 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02007
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 23, 2011
    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 IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED 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 BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) DURING DRAIN 5 OF 5 WITH A DRAIN VOLUME (DV)=5ML. THE HP STATED, HE HAD ALREADY DISCONNECTED FROM THE MACHINE BUT NEVER PLACED A FLEXICAP ON THE PATIENT LINE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CYCLE THE POWER ON THE MACHINE TO THE END OF THERAPY. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO END THERAPY. THE TSR ADVISED THE HP TO CONTACT THE NURSE. ON (B)(6) 2011 PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE CHECK PATIENT LINE ALARM. THE HP STATED HE RESUMED THERAPY USING NEW SUPPLIES WITHOUT ANY PROBLEMS. 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 85 YR HOMECHOICE APD SYSTEM/REF ((B)(4))