BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2992811 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05495
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE THAT THE EVENT OCCURED IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H10H11057 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A VISUAL INSPECTION NOTED THAT THE TRANSFER SET HAD BROKEN OCCLUDER FEET. THE SAMPLE CONFIRMED THE REPORTED PROBLEM. IT WAS REPORTED THAT THE CUSTOMER USES "BONADERM ULTRA" , WHICH IS AN ALCOHOL CONTAINING DISINFECTANT, TO CLEAN THE TRANSFER SET. ALCOHOL-CONTAINING DISINFECTANTS MAY WEAKEN THE TRANSFER SET MATERIAL, INCLUDING THE OCCLUDER FEET, AND POTENTIALLY CAUSE THE TRANSFER SET TO BECOME DAMAGED. THE CURRENT DIRECTION INSERT WHICH IS PROVIDED WITH THE AFFECTED TRANSFER SET INSTRUCTS THE PATIENT TO NOT APPLY HYDROGEN PEROXIDE, ALCOHOL OR ANTISEPTIC AGENTS CONTAINING ALCOHOL TO THE CONNECTORS.

    Description of Event or Problem · 1

    A DOCTOR REPORTED A LEAKING TRANSFER SET. WHEN THE CLAMP WAS TURNED, THE TRANSFER SET WOULD LEAK FROM THE DISTAL END OF THE TUBING. THERE WERE NO ADDITIONAL CLAMPS OR HEMOSTATS USED ON THE TUBING. THE TRANSFER SET HAD BEEN IN USE FOR BETWEEN 1 WEEK AND 3 MONTHS. THE DOCTOR USUALLY CHANGES OUT TRANSFER SETS EVERY 6 MONTHS. THE CLINIC USES "BONADERM ULTRA" ON TRANSFER SETS AS A DISINFECTANT, THE ACTIVE INGREDIENT IS (B)(6). THE PATIENT DOES NOT USE A TOOL TO OPEN OR CLOSE THE TRANSFER SET. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE TRANSFER SET THAT MAY HAVE CAUSED THE LEAK. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97712 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10H11057

    Patients

    Seq Age Sex Outcome Treatment
    1