BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2850724 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06112
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 15, 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). (B)(6). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE NO EVALUATION COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED BAXTER (B)(4) REGARDING A MISASSEMBLED MINICAP. THE DISTRIBUTOR REPORTED THE MINICAP'S SPONGE CAME OUT OF THE MINICAP. THERE WAS NO PATIENT INVOLVEMENT, AND 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 GM1205005

    Patients

    Seq Age Sex Outcome Treatment
    1