BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1873250 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04586
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 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 IS NOT AVAILABLE 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 A CHECK YOUR POSITION ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. FOLLOW UP WITH THE CAREGIVER REVEALED THEY DISCARDED THE SUPPLIES AND THEY STARTED OVER WITH NEW. THE CAREGIVER STATED THAT HER HUSBAND WAS ABLE TO CONTINUE WITH THERAPY. NO MEDICAL INTERVENTION OR PATIENT INJURY WAS ASSOCIATED WITH THIS REPORT.THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE 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 REPORT A CHECK YOUR POSITION ALARM ON THE HOMECHOICE DEVICE DURING FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) CHECK THE LINES FOR KINKS/FIBRIN. THE CG STATED THERE WAS AIR IN PATIENT LINE. THE TSR ADVISED THE CG WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE CG WHEN PRIMING WAS COMPLETED AND BEFORE CONNECTING, TO CHECK THE PATIENT LINE TO MAKE SURE THERE WAS NO AIR IN LINE.

    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 82 YR