BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM START-UP KIT

    MDR report key: 15127085 · Received July 28, 2022

    Report

    Report Number
    3010617000-2022-01266
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Report Date
    January 24, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K014241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. EVENT OF PE WAS ASSESSED AS SERIOUS DUE TO THE LIFE-THREATENING NATURE OF THE CONDITION. THE PATIENT WAS IMMOBILE AND PROBABLY HAD AN INFLAMMATORY RESPONSE DUE TO POST-CARDIAC ARREST SYNDROME (PCAS). THE PATIENT WAS IN A HIGH-RISK CATEGORY FOR DVT DUE TO IMMOBILITY AFTER CARDIAC ARREST. THERE WERE NO BLOOD COAGULOPATHY RESULTS AVAILABLE BEFORE INITIATION OF IVTM THERAPY. EVENT ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION OF DVT. AT THE SAME TIME, THE PATIENT'S POST CARDIAC ARREST CONDITION AND IMMOBILITY POSSIBLY CONTRIBUTED TO DEVELOPMENT OF CURRENT CONDITION OF DVT AND SUBSEQUENT PE. DVT IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. PATIENTS IN A CRITICAL CONDITION ARE TREATED WITH IVTM. IN SUCH CASES, THOSE CONDITIONS MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IS SUCH PATIENT POPULATION. CRITICALLY ILL PATIENTS ARE AT INCREASED RISK OF VTE BECAUSE OF THE PRESENCE OF MULTIPLE PREDISPOSING FACTORS [W. GEERTS, ET AL. VENOUS THROMBOEMBOLISM AND ITS PREVENTION IN CRITICAL CARE. J CRIT CARE, 17 (2002), PP. 95-104]. THE RATE OF THROMBOSIS FOR CRITICAL CARE PATIENTS RECEIVING CVCS RANGES FROM 20 TO 30%, PATIENTS WITH PERIPHERAL CENTRAL CATHETERS HAD A SIGNIFICANTLY HIGHER INCIDENCE RATE OF DVT THAN PATIENTS WITH CVC (27.2% VS 9.6%, P=0.0012). THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING IVTM POST-CARDIAC ARREST IS 1%. FOUR RANDOMIZED CONTROLLED CLINICAL TRIALS CONDUCTED IN A TOTAL OF 943 PATIENTS SHOWED THAT THERE WAS NO DIFFERENCE IN THE DVT RATE WHEN COMPARING ZOLL IVTM CATHETERS TO STANDARD CVCS. THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING SURFACE COOLING HAS BEEN REPORTED BETWEEN 3 AND 15%. TIMELY ADMINISTRATION OF PROPHYLACTIC ANTICOAGULATION IS SAFE AND SIGNIFICANTLY REDUCES DVT RATES IN HIGH-RISK PATIENT POPULATIONS [ZOLL WHITE PAPER ON DVT]. DVT OR PE IS ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER; EVENT WAS NOT SERIOUS. THE EVENT IS PROBABLY RELATED TO DEVICE AND IT IS NOT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    H10 (ADDTIONAL NARRATIVE/ DATA) WAS CORRECTED. THIS SUPPLEMENTAL MDR WAS CREATED TO RETRACT THE SUBMITTED MDR, AS THE START-UP KIT'S RELATIONSHIP TO THE EVENTS OF PE AND DVT WAS ASSESSED AS NOT RELATED. THEREFORE, THIS EVENT IS A NOT REPORTABLE.

    Description of Event or Problem · 0

    ON THE 3RD DAY OF IVTM THERAPY ON A RESUSCITATED PATIENT, CUSTOMER OBSERVED THAT THE PATIENT HAD HIGH D-DIMER LEVELS BUT DID NOT FIND LOWER LIMB DEEP VEIN THROMBOSIS (DVT). THE ICY CATHETER (LOT #UNKNOWN) WAS REMOVED AND WHEN PRESSURE WAS APPLIED TO THE INSERTION SITE TO STOP THE BLEEDING, THE CUSTOMER OBSERVED THAT THE PATIENT'S BREATHING AND PULSE WERE ABNORMAL. THE PATIENT'S LUNGS WERE CHECKED, AND EMBOLISM WAS FOUND IN BOTH MAIN BRONCHI OF THE LUNGS. AFTER CONSULTING WITH THE CARDIOLOGY DEPARTMENT, THE CUSTOMER DECIDED NOT PERFORM THROMBOLYSIS AND CONTINUE TO MONITOR THE PATIENT. BLOOD CLOTS WERE OBSERVED WHEN THE ICY CATHETER WAS REMOVED. NO ISSUES WITH THE CATHETER OR SUK. AS OF (B)(6) 2022, THE PATIENT'S HEALTH HAVE IMPROVED AND THE BLOOD CLOTS ARE GONE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00922 FOR THE ICY CATHETER (LOT# UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655066 ZOLL IVTM START-UP KIT CENTRAL VENOUS START UP KIT NCX ZOLL CIRCULATION 8700-0784-03 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other