BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1071507 · Received July 2, 2008

    Report

    Report Number
    1423500-2008-00587
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    February 28, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF CHIPPING/FLANKING OF THE LIGHT BLUE MAIN BODY AND DETENT OF THE TWIST CLAMP ON A TRANSFER SET. DURING EVALUATION, A CRACKED OCCLUDER FOOT WAS ALSO DISCOVERED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS ALSO PERFORMED, AND NO ISSUES WERE NOTED. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TENDS, AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    BAXTER (B) (4) REPORTED CHIPPING/FLANKING OF THE LIGHT BLUE MAIN BODY AND DETENT OF THE TWIST CLAMP ON A TRANSFER SET. IT WAS REPORTED THAT THE PATIENT USES OCTENISEPT AS A DISINFECTANT BEFORE EACH CONNECTION, BUT WILL STOP THIS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP TRANSFER SET/78KDJ KDJ BAXTER HEALTHCARE CORPORATION H07A24092

    Patients

    Seq Age Sex Outcome Treatment
    1