BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1873009 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04561
    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 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 DUE TO INSUFFICIENT INFORMATION. ON (B)(6) 2010,PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HOMEPATIENT REGARDING RECONNECTING THE FINAL BAG TO THE DISCONNECTED LINE. THE HOMEPATIENT STATED THAT IT WAS A MISTAKE AND THEY DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW. THE HOMEPATIENT ALSO STATED THAT HE WAS ABLE TO CONTINUE WITH THERAPY. THE HOMEPATIENT STATED THAT HE IS DOING WELL WITH THERAPY. NO MEDICAL INTERVENTION OR PATIENT INJURY WAS ASSOCIATED WITH THE REPORT. 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 DISCONNECTION FROM THE FINAL BAG WHILE CONNECTED THE HOMECHOICE DEVICE DURING DRAIN 1. THE CAREGIVER (CG) STATED SHE RECONNECTED THE FINAL BAG TO THE DISCONNECTED LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG WILL NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR EXPLAINED TO THE CG THAT ONCE THE LINE BECAME DISCONNECTED, IT WAS NO LONGER STERILE. IF THE HP CONTINUED USING THOSE SUPPLIES, THERE WAS A RISK OF INFECTION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP PAIN AND ELEVATED ION LEVELS.

    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 68 YR