BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2173533 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09341
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED. THIS REPORT WAS NOT CONFIRMED. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED 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) REPORTED TO BAXTER AFTER HOURS THAT HE THOUGHT THE CASSETTE WAS BAD. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CHECK THE LINES. THE HP STATED HE THOUGHT THE CASSETTE WAS LEAKING. THE TSR ADVISED THE HP TO CYCLE POWER TO END OF THERAPY AND PRESS ENTER. THE TSR FURTHER ASSISTED THE HP TO CHECK THE CASSETTE. THE HP CONFIRMED THE CASSETTE WAS LEAKING. THE TSR INSTRUCTED THE HP TO START OVER WITH ALL NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1