BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXD II

    MDR report key: 1811718 · Received August 23, 2010

    Report

    Report Number
    1423500-2010-02782
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED ISSUE OF THE HANDLE BEING JAMMED WAS CONFIRMED AND DUPLICATED DURING TESTING. THE SPIKE CARRIAGE GUIDE SPRING WAS REVEALED TO BE BENT PREVENTING THE SPIKE CARRIAGE FROM BEING GUIDED TO THE SPIKE POSITION AFTER COMPLETING THE UNSPIKE OPERATION. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO A BENT SPIKE CARRIAGE GUIDE SPRING. THE DEVICE IS NON-SERVICEABLE AND WILL BE DESTROYED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER REQUESTING A SWAP OF A COMPACT EXCHANGE DEVICE II (CXD). THE REGISTERED NURSE STATED THE CXD HANDLE WAS JAMMED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE INITIATED A SWAP. THE CXD WAS TO BE RETURNED TO BAXTER FOR EVALUATION. 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