BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1864252 · Received October 12, 2010

    Report

    Report Number
    1423500-2010-04322
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 18, 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). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED. 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.

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT THE BAG FALLING AND DISCONNECTING WHILE ON THE HOMECHOICE (HC) MACHINE DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOMEPATIENT (HP) CLOSE THE CLAMPS TO THE TUBING LINES AND RECYCLE POWER. THE TSR ASSISTED WITH ENDING THERAPY AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE PATIENT REGARDING THE DISCONNECTION. THE PATIENT STATED THAT THE BAG JUST FELL OFF THE TABLE AND SHE DOES NOT KNOW HOW IT HAPPENED. THE PATIENT STATED THAT HER SUPPLIES WERE FINE, HOWEVER, SHE DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW ONES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 52 YR