BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVTM START UP KIT

    MDR report key: 3889652 · Received June 23, 2014

    Report

    Report Number
    3003793491-2014-00294
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K014241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT A CORRECTION HAS BEEN MADE TO PMA/510(K). PLEASE NOTE THAT INITIAL REPORT INDICATED THAT "THE CASSETTE WAS CHANGED." ADDITIONAL CLARIFICATION WAS RECEIVED INDICATING THAT CHANGING THE "CASSETTE" MEANT CHANGING THE START-UP KIT (SUK). MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. THE START-UP KIT (SUK) IN COMPLAINT WAS RETURNED TO ZOLL ON 06/22/2014 FOR INVESTIGATION. EVALUATION OF THE RETURNED SUK COULD NOT CONFIRM OR REPLICATE THE CUSTOMER'S REPORTED EVENT AS NO LEAK PATH WAS OBSERVED WITH THE UNIT OR THE LUER CONNECTIONS. THERE WAS NO CRACK OR STRESS MARK NOTED AT THE MALE AND FEMALE LUER OF THE UNIT. THE UNIT FUNCTIONED AS INTENDED. PLEASE NOTE THAT DURING SUK MANUFACTURING, 100% OF THE UNITS ARE TESTED FOR PRESSURE FLOW, VOIDS AND DAMAGE TO ENSURE BOTH THE ABSENCE OF CRACKS, DAMAGE AND PRESSURE DISCREPANCIES THROUGHOUT THE DEVICE, AND THAT ALL TUBING LOCATIONS ARE FREE OF ANY LEAK PATHS. ONLY PASSING UNITS ARE MOVED TO THE NEXT PROCESS. IT WAS REPORTED THAT THE PATIENT DIED 3 DAYS AFTER SUK WAS REPLACED. THERE WERE NO DEVICE ISSUES REPORTED WITH THE REPLACED SUK. ADDITIONALLY, THE CUSTOMER DOES NOT ATTRIBUTE THE PATIENT'S DEATH TO THE IVTM PRODUCT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT ALTHOUGH PATIENT'S DEATH WAS NOT ATTRIBUTED TO ANY DEVICE MALFUNCTION OR HYPOTHERMIA PROCEDURE, THIS REPORT IS BEING SUBMITTED TO NOTIFY FDA OF THE DEATH. ZOLL HAS NOT YET RECEIVED THE IVTM START UP KIT 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 A (B)(6) HAD AN IN-HOUSE RESPIRATORY ARREST, WHICH TRIGGERED A CARDIAC ARREST. IT IS UNKNOWN HOW LONG THE PATIENT WAS IN THE HOSPITAL. NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR TO HYPOTHERMIA THERAPY. A ZOLL QUATTRO CATHETER WAS PLACED INTO THE RIGHT FEMORAL VEIN AT THE PATIENT'S BEDSIDE. INSERTION WAS SMOOTH AND MADE IN ONE ATTEMPT. THE TARGET TEMPERATURE WAS 33 DEGREES. ON (B)(6) 2014, A LEAK WAS OBSERVED ON THE PATIENT'S BEDDING AT 34.2 DEGREES. NO SYSTEM ALARMS WERE NOTICED DURING TREATMENT. THE CASSETTE WAS CHANGED. PATIENT EXPIRED ON (B)(6) 2014 AT 11:22 AM. HOWEVER, PATIENT'S DEATH WAS NOT ATTRIBUTABLE TO THE ZOLL PRODUCT OR THE HYPOTHERMIA THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365078 IVTM START UP KIT CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0666-01 044897

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other