BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4171620 · Received October 14, 2014

    Report

    Report Number
    1416980-2014-35896
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AN EXTRA, UNREPORTED SAMPLE WAS RECEIVED ALONG WITH THE SAMPLE FOR (B)(4). A VISUAL INSPECTION FOUND THAT THIS EXTRA SAMPLE HAD BEEN OPENED FOR TWO MONTHS AND ITS IODINE SPONGE WAS DRY. THE IODINE CONTENT OF THE SAMPLE WAS EVALUATED AND FOUND TO MEET SPECIFICATION. THE DRY SPONGE CONDITION WAS VERIFIED FOR THE OPEN SAMPLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE CAUSE OF THE PROBLEM COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE PATIENT'S ADDRESS IS "(B)(6)". THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UPON EVALUATION OF A RETURNED SAMPLE, IT WAS NOTED THAT THE SPONGE OF THE MINICAP WAS DRY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650121 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1309010

    Patients

    Seq Age Sex Outcome Treatment
    1