BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1912735 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06455
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 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 WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR SEPARATION - CONNECTION ISSUE OF A SUPPLY BAG WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION THE CAUSE OF THE COMPLAINT IS USER ERROR. PER THE COMPLAINT INFORMATION, THE PATIENT STATED THE SUPPLY BAG WAS NOT SPIKED PROPERLY. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING NEEDING ASSISTANCE GETTING THE CASSETTE OUT THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING PRIMING. THE HP STATED HE COMPROMISED THE LINES BY NOT SPIKING THE BAGS CORRECTLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO PRESS STOP, CYCLE POWER AND REMOVE THE CASSETTE. THE HP DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW ONES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER 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 73 YR