BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2122995 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07599
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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

    BAXTER CLINICAL EDUCATOR (CE) LEFT A VOICE MESSAGE FOR CORPORATE PRODUCT SURVEILLANCE (CPS) TO RELAY REPORT RECEIVED FROM A DIALYSIS UNIT HEALTHCARE PROFESSIONAL ON AN UNKNOWN DATE FOR ONE (1) UNSPECIFIED TRANSFER SET THAT "CAME DISCONNECTED" ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1