BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2820823 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04158
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - CUERNAVACA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A MISASSEMBLED MINICAP WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A SAMPLE EVALUATION WAS PERFORMED AND THE POVIDONE IODINE WAS CONTAINED IN THE SPONGE WITHIN THE MINICAP. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER AN ISSUE OF A MISASSEMBLED MINICAP FOUND BEFORE USE. THE CUSTOMER REPORTED THAT THE FOAM WITH IODINE WAS NOT INSIDE OF THE MINICAP. THE PRODUCT WAS NOT USED ON A PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 - CUERNAVACA M11H28A

    Patients

    Seq Age Sex Outcome Treatment
    1