BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1862331 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04188
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAD REPORTED LEAK IN 14 TRANSFER SETS. THIS IS THE 3RD OF THE 14 EMDRS BEING SUBMITTED. PER THE CUSTOMER, THE SAMPLE WAS NOT AVAILABLE. THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). THIRD OF 14 EMDRS. THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. A BATCH REVIEW FOR THE MANUFACTURING LOT NUMBER (H09K16088) SHOWED NO RELATED PRODUCTION PROBLEMS. COMPLAINT TEXT INDICATES THAT THE CENTER HAD TRAINED THE PATIENTS TO VERY TIGHTLY LOCK THE CAP OF THE TRANSFER SET. THIS COULD BE THE ROOT CAUSE OF THE FAILURE, BUT NO SAMPLE WAS AVAILABLE TO VERIFY THIS AND DETERMINE ROOT CAUSE. 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.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE CONTACTED BAXTER TO REPORT THAT THE TRANSFER SET WAS LEAKING AND BROKEN. NO PATIENT INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    LEAKS OCCURRED IN 14 DIFFERENT TRANSFER SETS. ALL THE 14 TRANSFER SETS WERE FROM THE SAME LOT NUMBER. UPON FURTHER INVESTIGATION BY A BAXTER NURSE ON SITE, IT WAS FOUND THAT THE CENTER HAD TRAINED THE PATIENTS TO VERY TIGHTLY LOCK THE CAP OF THE TRANSFER SET. THE NURSE NOTED THAT IT MIGHT BE THE ROOT CAUSE OF LEAKING TRANSFER SETS AT THIS CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H09K16088

    Patients

    Seq Age Sex Outcome Treatment
    1