BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2120644 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07459
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REQUESTED. "THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S." SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. THIS REPORT ADDRESSES PRODUCT QUANTITY 39 OF 60.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE WEIGHT OF THE IODINE IN THE CLOSED POUCH SAMPLE RETURNED WAS CALCULATED AND FOUND TO BE GREATER THAN THE MINIMUM VALUE OF IODINE REQUIRED TO DISINFECT THE TRANSFER SET. THE REPORTED CONDITION WAS NOT CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO THE BAXTER SALES REPRESENTATIVE THAT AFTER A PATIENT THERAPY, THE PATIENT OPENED THE MINICAP AND OBSERVED THAT THE IODINE WITHIN THE SPONGE WAS INADEQUATE. THE PATIENT WAS WORRIED ABOUT INFECTION DUE TO INADEQUATE IODINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 10L06H15

    Patients

    Seq Age Sex Outcome Treatment
    1