BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2872807 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07278
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER CHINA THAT THE IODINE LIQUID IN THE MINI CAP WAS INSUFFICIENT. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 - GUANGZHOU

    Patients

    Seq Age Sex Outcome Treatment
    1