BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1811732 · Received August 23, 2010

    Report

    Report Number
    1423500-2010-02786
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE. THE ROOT CAUSE WAS DUE TO THE PATIENT CONNECTING TO THE PATIENT LINE PRIOR TO ADEQUATE PRIMING OF THE LINES. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING BEING CONNECTED DURING THE PRIME CYCLE ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) STATED HE CONNECTED HIMSELF TO THE PATIENT LINE BY MISTAKE DURING PRIME. THE HP ASEPTICALLY DISCONNECTED FROM THE HC. THE HP WAS ADVISED TO CONTACT THEIR PERITONEAL DIALYSIS NURSE ABOUT THE INCIDENT. PRODUCT SURVEILLANCE SPOKE TO THE HP ON (B)(6) 2010. THE HP STATED HE DISCARDED THE SET-UP AND STARTED OVER WITH NEW SUPPLIES. THE HP STATED HE IS FEELING WELL AND IS CONTINUING THERAPY ON THE HC WITH NO FURTHER ISSUES. 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 54 YR