BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXD II

    MDR report key: 1821867 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03029
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    STNK851208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CUSTOMER REPORT OF THE CXD NOT WORKING WAS CONFIRMED AND DUPLICATED BY VISUAL AND FUNCTIONAL TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A BENT SPIKE CARRIAGE GUIDE SPRING, WHICH WAS PREVENTING THE SPIKE CARRIAGE FROM BEING GUIDED TO THE SPIKE POSITION AFTER COMPLETING THE UNSPIKE OPERATION. THE DEVICE IS NON-SERVICEABLE AND WILL BE DESTROYED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REQUESTING A SWAP OF A COMPACT EXCHANGE DEVICE II (CXD). THE HOME PATIENT (HP) STATED THAT THE CXD WAS NOT WORKING AND WAS BROKEN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORTED INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR