BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUASHIELD

    MDR report key: 2181460 · Received July 19, 2011

    Report

    Report Number
    2181460
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 19, 2011
    Manufacturer
    EQUASHIELD MEDICAL LTD.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EQUASHIELD FEMALE AND MALE LUER PARTS WERE CONNECTED TO THE IV TUBING, BUT CHEMOTHERAPY DRUG WOULD NOT INFUSE. ADJUSTMENTS WERE MADE WITHOUT SUCCESS. THE DEVICE WAS REMOVED AND INFUSION RAN WITHOUT FURTHER PROBLEMS.======================MANUFACTURER RESPONSE FOR EQUASHIELD, EQUASHIELD (PER SITE REPORTER)======================STILL ATTEMPTING TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUASHIELD EQUASHIELD LHI EQUASHIELD MEDICAL LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR CHEMOTHERAPY