BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM SOLEX CATHETER

    MDR report key: 7981173 · Received October 18, 2018

    Report

    Report Number
    3010617000-2018-01060
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    August 9, 2018
    Report Date
    October 2, 2023
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K770977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED THAT EVENT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). NO PATIENT INJURY ATTRIBUTABLE TO ZOLL PRODUCT, NO IMPACT OR CONSEQUENCE TO PATIENT. BASED ON LIMITED INFORMATION PROVIDED, EVENT WAS POSSIBLY RELATED TO THE ICY CATHETER DUE TO RELEVANT TIMING AND LOCATION. IT WAS POSSIBLE THAT CATHETER WAS INSERTED NOT FAR ENOUGH. THE EVENT OF SWELLING IS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE ZOLL CATHETER IN COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(4) 2018, ZOLL RECEIVED A MEDWATCH REPORT (MW5079677) FROM THE FDA THAT A PATIENT WAS ADMITTED FOR HYPOTHERMIA AND A SOLEX COOLING CATHETER WAS PLACED ON THE PATIENT BUT AFTER A BOLUS OF IVF OF 1000 CC, IT WAS NOTED THAT THE SUBCUTANEOUS TISSUE AROUND THE CATHETER WAS EDEMATOUS (SWELLING), NO CREPITUS NOTED. CARDIAC PRESSORS HAD BEEN INFUSING VIA THAT SOLEX CATHETER AS WELL. ONCE THE EDEMA WAS NOTED, THE CATHETER WAS NO LONGER USED FOR DRUG INFUSION. PATIENT WAS ALREADY ON A VENT, NO APPARENT IMMEDIATE HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820525 ZOLL IVTM SOLEX CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0793-01 UNKNOWN 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention