BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100" 20 DROP Y-TYPE BLOOD SET

    MDR report key: 6085118 · Received November 8, 2016

    Report

    Report Number
    2025816-2016-00213
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K954813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT# 3273195 SHOWED THAT 2,800 UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN (B)(4) 2016, CITING NO EXCEPTION DOCUMENTS. NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE K098-001, 100" 20 DROP Y-TYPE BLOOD SET W/200 MICRON FILTER, HAND PUMP, 2 CLAVES, ROTATING LUER AND FILTER CAP, LOT# 3273195 (MFD. JUNE 2016). REPORT STATES "WE UTILIZE THESE GRAVITY BLOOD SET TO INFUSE STEM CELL TRANSPLANTS. TODAY THE ENTIRE SET HAD TO BE CHANGED AFTER ABOUT 80% OF THE TRANSFUSION HAD BEEN COMPLETED WHEN THE HANDPUMP HAD EMPTIED OUT AND AIR BUBBLES WERE STARTING TO TRAVEL TOWARD THE PATIENT'S CENTRAL VENOUS CATHETER. THERE WAS NO WAY TO GET FLUID BACK INTO THE HANDPUMP. WE LOST SEVERAL MLS OF STEM CELL PRODUCT WHEN THIS SET HAD TO BE CHANGED OUT AND A NEW SET HAD TO BE USED. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737871 100" 20 DROP Y-TYPE BLOOD SET 100" 20 DROP Y-TYPE BLOOD SET FPA ICU MEDICAL, INC. K098-001 3273195

    Patients

    Seq Age Sex Outcome Treatment
    1