BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1972286 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01163
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR CHECK LINE AND BAGS ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE ROOT CAUSE WAS DETERMINED TO BE THE SUPPLY BAG DISCONNECTING WITHOUT FALLING. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 4. THE FINAL BAG BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED TO END THERAPY. THE HOME PATIENT (HP) WILL CALL THE NURSE REGARDING THE MISSED THERAPY AND BEING CONNECTED WHEN THE BAG BECAME DISCONNECTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 HOMECHOICE CYCLER