BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1850750 · Received October 2, 2010

    Report

    Report Number
    1423500-2010-04017
    Event Type
    Malfunction
    Date Received
    October 2, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF AN OVERPRIME. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED; LOT INFORMATION IS UNKNOWN. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING FLUID SHOOTING OUT OF THE PATIENT LINE DURING PRIME ON THE HOMECHOICE (HC) UNIT. THE HP STATED SHE PRESSED STOP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PLACEMENT OF SUPPLY LINES WITH THE HP. THE HP STATED SHE HAD THE DRAIN LINE STILL PLACED IN THE ORGANIZER AND THE PATIENT LINE MISPLACED. THE TSR INSTRUCTED THE HP TO CLOSE ALL THE CLAMPS, TO CYCLE POWER OFF, AND TO RETURN TO THE PRESS GO TO START PROMPT. THE HP STATED SHE WOULD START OVER WITH A NEW SET UP TO COMPLETE THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 39 YR