BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXD II

    MDR report key: 1781411 · Received August 3, 2010

    Report

    Report Number
    1423500-2010-01851
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT OF THE COMPACT EXCHANGE DEVICE (CXD) NOT SPIKING WAS CONFIRMED AND DUPLICATED DURING THE EVALUATION PERFORMED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL PERFORMED A SPIKE AND UNSPIKE OPERATION USING A SPIKE AND UNSPIKE TEST SET. THE TEST FAILED. A VISUAL INSPECTION REVEALED THE SPIKE CARRIAGE WAS DAMAGED PREVENTING IT FROM BEING GUIDED TO THE SPIKE POSITION AFTER COMPLETING THE UNSPIKE OPERATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE A DAMAGED SPIKE CARRIAGE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A COMPACT EXCHANGE DEVICE(CXD) NOT SPIKING THE BAGS CORRECTLY. THE REGISTERED NURSE REQUESTED A SWAP AND DID NOT HAVE THE SERIAL NUMBER OF THE CXD. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE ARRANGED FOR THE SWAP. 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 CXD II SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1