BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4151253 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-34978
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 11, 2014
    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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: FACILITY NAME - (B)(6). A COMPANION SAMPLE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER GM1402101 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED PROBLEM WERE NOTED. A VISUAL INSPECTION WAS PERFORMED AND THE MINICAP WAS FOUND OPENED AND THE SPONGE WAS INSIDE OF FOIL POUCH BUT OUT OF THE MINI CAP. THE REPORTED PROBLEM WAS VERIFIED VIA VISUAL INSPECTION. THE CAUSE FOR THE REPORTED PROBLEM WAS UNDETERMINED. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINICAP SPONGE CAME OUT FROM THE MINICAP. THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632543 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1402101

    Patients

    Seq Age Sex Outcome Treatment
    1