BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFSET

    MDR report key: 2213506 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10774
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. WE WERE UNABLE TO DUPLICATE THE COMPLAINT UNDER LAB CONDITIONS WITH THE RETURNED SAMPLE AND, THEREFORE, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE RETURNED SAMPLE RETURNED DID NOT SHOW ANY CONNECTION PROBLEMS OR LEAKAGE. THE LOT NUMBER WAS NOT KNOWN SO NO BATCH REVIEW WAS PERFORMED. IN THIS CASE THE EVALUATIONS DID NOT FIND ANY EVIDENCE OF ANY PROBLEM. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED TO BAXTER (B)(4) THAT THE CATHETER CONNECTOR OF PD TRANSFER SET WAS SEPARATED FROM THE TITANIUM ADAPTER AFTER 3 MONTHS USE. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFSET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTOR