BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1993976 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02051
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 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 LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AN OVERPRIME - LEAK OUT OF PATIENT LINE. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND NO ROOT CAUSE WAS DETERMINED. 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.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED (B)(4) WITH A QUESTION ABOUT THE PRIME THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING PRIME. THE CG STATED FLUID CAME OUT OF THE TOP OF THE PATIENT LINE AFTER THE PRIME WAS COMPLETE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THIS IS A NORMAL OCCURRENCE, THAT THE SET UP WAS STILL STERILE AND THAT THERE WAS A VENTED CAP ON THE PATIENT LINE. THERE WAS PATIENT INVOLVEMENT, BUT NO MEDICAL INTERVENTION OR INJURY WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE; THE CG STATED THAT THE HOME PATIENT (HP) FINISHED THERAPY WITH THAT CASSETTE AND THEN DISCARDED IT. THE LOT NUMBER WAS NOT KNOWN. THE HP HAS CONTINUED THERAPY NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    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 76 YR HOME CHOICE CYCLER