BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2841951 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05719
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 7, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE REPORTED ISSUE WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, AN ASSIGNABLE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER AN ISSUE OF INADEQUATE IODINE FOUND BEFORE USE. THE IODINE LIQUID AT THE MINI CAP IS INSUFFICIENT.THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    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