BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT EXCHANGE DEVICE

    MDR report key: 2073210 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05220
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION IN THE PRODUCT ANALYSIS LAB(PAL). THE PAL TECHNICIAN PERFORMED THE SPIKE AND UNSPIKE OPERATION USING THE SPIKE AND UNSPIKE TEST SET. SPIKE AND UNSPIKE OPERATION PERFORMED CORRECTLY WITHOUT MALFUNCTION. THE REPORTED ISSUE OF CXD WAS NOT WORKING, WAS NOT CONFIRMED OR DUPLICATED BY FUNCTIONAL TEST. THE CXD WAS FOUND TO BE FUNCTIONAL. THE CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. THE DEVICE IS NON-SERVICEABLE AND WILL BE DESTROYED. THE DEVICE WAS FORWARDED TO BE DESTROYED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER'S (B)(4) AND REQUESTED A SWAP OF A COMPACT EXCHANGE DEVICE II (CXD). THE REGISTERED NURSE (RN) STATED THAT THE CXD WAS NOT WORKING. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INITIATED A SWAP. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORTED INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1