BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 12140212 · Received July 8, 2021

    Report

    Report Number
    3010617000-2021-00576
    Event Type
    Death
    Date Received
    July 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    August 8, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:B5 THE QUATTRO CATHETER WILL NOT BE RETURNING FOR INVESTIGATION BECAUSE THE PATIENT WAS A MEDICAL EXAMINER CASE. PATIENT WITH MULTIPLE SERIOUS COMORBIDITIES PRESENTED TO THE ED IN SHOCK AND WITH HYPOTHERMIA; ADMITTED TO ICU AND TREATED FOR MULTIPLE SERIOUS PROBLEMS. PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED BY THE CUSTOMER. ZOLL THERMOGARD LX WITH QUATRO CATHETER WAS USED IN AN ATTEMPT TO WARM THE PATIENT. THE QUATTRO CATHETER INSERTION WAS SMOOTH BY AN EXPERIENCED PHYSICIAN. CATHETER WAS PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN. THE 500ML NS BAG WAS NOTED TO BE EMPTY AND QUATTRO SYSTEM WAS PULLING AIR INTO THE AIR TRAP. THE SYSTEM WAS PLACED ON STANDBY, RE-PRIMED & DURING PRIMING, BLOOD WAS NOTED IN CLOSED SYSTEM TUBING OF ORANGE PORT, AND USE DISCONTINUED. QUATTRO CATHETER LEAK WAS SUSPECTED. THE CATHETER DWELL TIME WAS LESS THAN 12 HOURS, POSSIBLY 6 HOURS. CUSTOMER REPORTED THAT SUCH ISSUE OCCURRED FIRST TIME IN THEIR USE OF ZOLL CATHETERS. ULTIMATELY, THE PATIENT PASSED AWAY. THE OFFICIAL CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME, BUT PRELIMINARY FINDINGS SUGGEST IT WAS DUE TO HIS UNDERLYING SERIOUS MEDICAL CONDITIONS. SEEMS THAT 500ML OF STERILE NS COULD BE ENTERED IN THE PATIENT'S VASCULATURE. ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS AND SHOULD NOT HARM A PATIENT. THE FLUID RAN INTO THE PATIENT'S VASCULATURE IS AN ANTICIPATED EVENT. NO PATIENT'S EFFECT WAS OBSERVED.

    Description of Event or Problem · 0

    ON JULY 21, 2021, ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER, THE CATHETER DWELL TIME WAS LESS THAN 12 HOURS , POSSIBLY 6 HOURS. CATHETER WAS NOT RETURNED BECAUSE THE PATIENT WAS A MEDICAL EXAMINER CASE. THE QUATTRO CATHETER INSERTION WAS SMOOTH BY AN EXPERIENCED PHYSICIAN. CATHETER WAS PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN. PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. PATIENT WITH MULTIPLE SERIOUS COMORBIDITIES PRESENTED TO THE ED IN SHOCK AND WITH HYPOTHERMIA; ADMITTED TO ICU AND TREATED FOR MULTIPLE SERIOUS PROBLEMS. ZOLL THERMOGARD LX WITH QUATRO CVCATHETER WAS USED IN AN ATTEMPT TO WARM THE PATIENT. THE 500ML NS BAG WAS NOTED TO BE EMPTY AND QUATTRO SYSTEM WAS PULLING AIR INTO THE AIR TRAP. THE SYSTEM WAS PLACED ON STANDBY, RE-PRIMED & DURING PRIMING, BLOOD WAS NOTED IN CLOSED SYSTEM TUBING OF ORANGE PORT, AND USE DISCONTINUED. THE 500ML NS BAG WAS NOTED TO BE EMPTY AND THE THERMOGARD CONSOLE WAS PULLING AIR INTO THE AIR TRAP (BUBBLES). THE SYSTEM WAS PLACED ON STANDBY, RE-PRIMED & DURING PRIMING, BLOOD WAS NOTED IN THE TUBING OF ORANGE PORT, AND USE DISCONTINUED. QUATTRO CATHETER LEAK WAS SUSPECTED. CUSTOMER REPORTED THAT SUCH ISSUE OCCURRED FIRST TIME IN THEIR USE OF ZOLL CATHETERS. ULTIMATELY, THE PATIENT PASSED AWAY. THE OFFICIAL CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME, BUT PRELIMINARY FINDINGS SUGGEST IT WAS DUE TO HIS UNDERLYING SERIOUS MEDICAL CONDITIONS. SEEMS THAT 500ML OF STERILE NS COULD BE ENTERED IN THE PATIENT'S VASCULATURE. ADMINISTRATION OF STERILE COLD SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS AND SHOULD NOT HARM A PATIENT. RE-TRAINING OF THE CUSTOMER ON USAGE OF THE CATHETER TO ASSURE APPROPRIATE LOCATION OF THE CATHETER DURING COOLING THERAPY COULD BE BENEFICIAL. DEATH WAS NOT RELATED TO ZOLL DEVICE.

    Description of Event or Problem · 1

    DURING IVTM THERAPY ON A PATIENT WITH MULTIPLE SERIOUS COMORBIDITIES PRESENTED TO THE EMERGENCY DEPARTMENT IN SHOCK AND WITH HYPOTHERMIA; ADMITTED TO ICU AND TREATED FOR MULTIPLE SERIOUS PROBLEMS. THE 500ML NS BAG WAS NOTED TO BE EMPTY AND THE THERMOGARD CONSOLE WAS PULLING AIR INTO THE AIR TRAP (BUBBLES). QUATTRO CATHETER (LOT #UNKNOWN) LEAK IS SUSPECTED. THE SYSTEM WAS PLACED ON STANDBY, RE-PRIMED & DURING PRIMING, BLOOD WAS NOTED IN THE TUBING OF ORANGE PORT, AND THERAPY WAS DISCONTINUED. PER CUSTOMER, THE THERMOGARD CONSOLE IS FUNCTIONING PROPERLY. PATIENT DEATH WAS REPORTED. THE OFFICIAL CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME, BUT PRELIMINARY FINDINGS SUGGEST IT WAS DUE TO HIS UNDERLYING SERIOUS MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036569 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 Death