BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 3945427 · Received July 21, 2014

    Report

    Report Number
    3003793491-2014-00360
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 12, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZOLL ICY CATHETER INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION. ICY-3 CATHETER HUBS (INFLOW, OUTFLOW, PROXIMAL, MEDIAL AND DISTAL) ARE DESIGNED TO ADHERE TO STANDARD MEDICAL LUER CONNECTORS. IN/OUTFLOW LUERS ARE VISUALLY DIFFERENTIATED FROM INFUSION LUERS (INDICATED BY "CUSTOMER REQUIREMENTS ICY 3", DOC#(B)(4)). THIS SEGREGATION COLOR CODING SCHEME IS INTENDED FOR USER FAMILIARITY (PER "DESIGN SPECIFICATION ICY IC-3893 ALL VARIANTS", DOC# (B)(4)). THERE IS A WARNING ON THE PRODUCT IFU ("IFU ICY", DOC# (B)(4)) WHICH EXPLICITLY STATES, "DO NOT CONFUSE THE INFLOW AND OUTFLOW LUER FITTINGS FOR STANDARD CENTRAL LINE INFUSION PORTS. THEY ARE FOR CONNECTION TO THE COOLGARD 3000 SYSTEM ONLY." IN ADDITION, ONLY ATTENDING PERSONNEL WHO ARE TRAINED TO THESE INSTRUCTIONS SHOULD BE OPERATING THE SYSTEM DURING PATIENT TREATMENT. FURTHERMORE, PROBABLE CAUSE FOR THE CUSTOMER'S REPORTED PROBLEM MIGHT BE DUE TO USER ERROR. IT WAS REPORTED THAT THE PATIENT OUTCOME WAS NOT DUE TO THE USER CONNECTION ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT CAME INTO THE HOSPITAL FOR CARDIAC ARREST. THE EMERGENCY DEPARTMENT (ED) STAFF NURSE PLACED THE ZOLL IVTM ICY CATHETER INTO THE PATIENT. UPON TRANSFER FROM THE ED TO THE CRITICAL CARE UNIT (CCU), THE CCU NURSE NOTED A CONNECTION ERROR IN WHICH VASOPRESSORS WERE CONNECTED TO THE INFLOW LUMEN OF THE BALLOON PORT. THE OUTFLOW PORT WAS LEFT OPEN TO AIR, WHICH RESULTED IN UNDELIVERED MEDICATIONS. THIS CONNECTION ERROR WAS IMMEDIATELY CORRECTED. THE PATIENT HAD A LARGE INTRACEREBRAL HEMORRHAGE (ICH). THEREFORE, COOLING THERAPY WITH THE ZOLL DEVICE WAS NOT PERFORMED. PATIENT HAS SINCE EXPIRED. PER THE CUSTOMER, THE PATIENT OUTCOME WAS NOT DUE TO THE CONNECTION ERROR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426278 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0657-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1