BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 5527902 · Received March 25, 2016

    Report

    Report Number
    3010617000-2016-00203
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Date of Event
    February 17, 2016
    Report Date
    March 25, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075138
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE ZOLL CATHETER IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT, THE PATIENT WAS NOT COOLING AS EXPECTED USING THE QUATTRO CATHETER. THE HOSPITAL STAFF ALSO STATED THAT THEY COULD NOT INFUSE MEDICATION OR FLUIDS THROUGH THE CATHETER. NO PATIENT INFORMATION WAS DISCLOSED. A NEW QUATTRO CATHETER WAS PLACED USING A GUIDEWIRE. NO OTHER ISSUES WERE REPORTED. NO PATIENT SEQUELAE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182981 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0660 UNKNOWN 00849111075138

    Patients

    Seq Age Sex Outcome Treatment
    1