BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2063603 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04737
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 25, 2011
    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). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED AND EVALUATED IN THE CHEMICAL LAB. THE REPORTED CONDITION WAS NOT CONFIRMED; NO EXCEPTION WAS FOUND AFTER CHEMICAL TEST. A REVIEW OF THE BATCH REVEALED NO EXCEPTION REGARDING THIS ISSUE FOUND IN THE MANUFACTURING PROCESS. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT THERE WAS INADEQUATE IODINE IN THE MINICAP. THERE WAS NO PATIENT 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 - GUANGZHOU GM1101023

    Patients

    Seq Age Sex Outcome Treatment
    1