BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 11963177 · Received June 8, 2021

    Report

    Report Number
    3010617000-2021-00561
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 8, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE QUATTRO CATHETER (LOT# UNKNOWN) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE CATHETER IS RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING COOLING PHASE OF IVTM THERAPY, THE USER OBSERVED BLOOD IN THE START-UP KIT TUBING, SUSPECTING A LEAK ON THE QUATTRO CATHETER (LOT# 153696). AFTER REMOVING THE CATHETER, THE USER TRIED TO REWIRE ANOTHER QUATTRO CATHETER (SN UNKNOWN), HOWEVER,WAS UNABLE TO PERFORM CATHETERIZATION. FOLLOWING THIS, IVTM THERAPY WAS DISCONTINUED AND ADJUNCT THERAPY WAS PERFORMED. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00543 FOR QUATTRO CATHETER LOT# 135696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850445 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1