BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2141112 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08382
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND NO FURTHER INFORMATION ABOUT ANY PRODUCT PROBLEM IS AVAILABLE, NO ROOT CAUSE CAN BE 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.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER (CG) ON (B)(6) 2011 REGARDING A SEPARATE ISSUE WHEN THE CG STATED THAT ON (B)(6) /2011 THE HOME PATIENT (HP) WOKE UP AND FOUND THAT HERSELF AND THE BED WERE WET. THE HP THEN NOTICED THAT THE TRANSFER SET WAS LOOSE AND HAD LEAKED. THE HP ENDED THERAPY AND CONTACTED HER NURSE. THE HP SAW THE NURSE AT THE CLINIC THE FOLLOWING MORNING. THE CG SAID THE HP WAS GIVEN A NEW TRANSFER SET AND ANTIBIOTICS. THERE WAS NO PATIENT INJURY INDICATED AT THE TIME OF THE INITIAL REPORT. NO FURTHER INFORMATION AVAILABLE. THERE WAS PATIENT INVOLVEMENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE