BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1971756 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01115
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A DAMAGED TRANSFER SET WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT 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 IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR REFERENCED RELATED REPORT, THE HOME PATIENT (HP) CONFIRMED THE INITIAL REPORT THAT PIECES OF THE COTTON IN THE MINICAP WERE COMING OFF AND CLOGGING THE LINE. THE HP STATED HE TOOK THE MINICAPS TO THE CLINIC TO SHOW HIS NURSE (PDRN). THE HP STATED THE PDRN LOOKED AT THE TRANSFER SET TUBING UNDER A MAGNIFYING GLASS AND FOUND THERE WAS A SHARP EDGE THAT COULD HAVE BEEN CAUSING THE PROBLEM. THE HP STATED HE HAD THE TRANSFER SET FOR ABOUT A WEEK OR TWO AND HAD PROBLEMS WITH ABOUT 4 OR 5 MINICAPS. THE HP STATED THEY CHANGED THE TRANSFER SET AND HE HAD NOT HAD A PROBLEM SINCE. NO PATIENT 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 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR