BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1884400 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04995
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 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 IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PATIENT CONTAMINATING THE LINE WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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 CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REQUEST HELP WITH ENDING THERAPY ON THE HOMECHOICE DEVICE DURING DWELL 5 OF 10. THE HOMEPATIENT (HP) DISCONNECTED FROM THE PATIENT LINE AND DROPPED IT ON THE FLOOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH ENDING THERAPY. THE HP WOULD USE MANUAL SUPPLIES TO COMPLETE THERAPY. FOLLOW UP WITH THE NURSE REVEALED THAT THE PATIENT DID CALL HER AND HE WAS TREATED PROPHYLACTICALLY WITH ANTIBIOTICS. THE NURSE STATED THAT THE SUPPLIES WERE DISCARDED AND THE PRODUCT INFORMATION WAS UNKNOWN. NO ALLEGATIONS WERE MADE AGAINST THE PRODUCTS AND DEVICE.

    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 59 YR