BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3241602 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-18970
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS LOT NUMBER GD894394 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. THEREFORE, NO DEVICE ANALYSIS CAN BE PERFORMED AND NO CAUSE WAS DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 FOR THIS PATIENT AND EVENT. IT WAS REPORTED THAT THERE WAS A LEAK ON A MINICAP DURING USE ON A HOME PATIENT (HP). DURING FOLLOW-UP, THE HP STATED THAT IODINE HAD LEAKED ONTO HIS BED SHEETS AND HANDS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340440 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND G0894394

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR