BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2052262 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04407
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS COMPLAINT FOR LEAK WAS CONFIRMED, THE RESULTS OF A SAMPLE EVALUATION REVEALED A CUT APPROXIMATELY 7/8 FROM SLEEVE IN CLOSED POSITION. THE RESULTS OF A BATCH REVIEW REVEALED NO PROBLEMS DURING THE MANUFACTURING PROCESS AND NO DEVIATIONS FROM STANDARD PROCEDURE. A ROOT CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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 SAMPLE WAS REQUESTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A NURSE FROM (B)(6) REPORTED TO BAXTER THAT A TRANSFER SET WAS CHANGED IN THE HOSPITAL AND UPON THE PATIENT RETURNING HOME, THE NURSE OF THE PATIENT OBSERVED A LEAK ON THE TRANSFER SET. THE TRANSFER SET WAS CHANGED IMMEDIATLY. THE PATIENT WAS ALREADY UNDER ANTIOBIOTHERAPY. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H06K15067

    Patients

    Seq Age Sex Outcome Treatment
    1