BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1802479 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02578
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 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). A SAMPLE WAS NOT RECEIVED FOR EVALUATION, HOWEVER, PER THE COMPLAINT DESCRIPTION, THE SPIKE SEPARATED FROM THE BAG DUE TO USE ERROR. THE USER HAD NOT FULLY SEATED THE SPIKE IN THE BAG PORT. THEREFORE, THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. LABELING REVIEW FOUND THAT THE DIRECTION INSERT FOR THE DISPOSABLE SET STATES IN THE SPIKING PROCEDURE BOX THAT AFTER THE TIP PROTECTORS ARE REMOVED, "IMMEDIATELY INSERT SPIKE INTO CONTAINER UNTIL IT IS FULLY SEATED." THE USER MANUAL STATES IN THE CAUTIONS AND WARNING SECTION TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING YOUR THERAPY. A BATCH REVIEW OF THE REPORTED LOT NUMBER WAS FOUND TO BE ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AS IT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE ADJUSTABLE BAND, THE PORT WAS NOTED TO HAVE FLIPPED ON (B)(6) 2010. THE PORT WAS REPLACED ON (B)(6) 2010 WITH REPORTED PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A CHECK HEATER LINE ALARM ON THE HOMECHOICE (HC) MACHINE DURING THE FILL CYCLE. DURING TROUBLESHOOTING, THE HOME PATIENT (HP) DISCOVERED THAT THE SPIKE WASN'T IN ALL THE WAY. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE SHE WAS NOT AWARE OF THIS EVENT, HOWEVER, THE PATIENT HAS BEEN SEEN SINCE THIS EVENT AND HAS RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. ACCORDING TO THE PATIENT THERE WAS NO DEFECT WITH THE CASSETTE. THE PATIENT STATED HE JUST FAILED TO FULLY SPIKE THE BAG. THE PATIENT STATED HE HAS NOT HAD ANY FURTHER ISSUES.

    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 H10E23025

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR