BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2123602 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07612
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. SAMPLE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT THE CAP IS BROKEN AND THE SOLUTION CAME OUT. PATIENT INJURY AND MEDICAL INTERVENTION WERE NOT REPORTED FOR THIS EVENT. PATIENT NOT INVOLVED.

    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 - CALI

    Patients

    Seq Age Sex Outcome Treatment
    1