BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 12425989 · Received September 3, 2021

    Report

    Report Number
    3010617000-2021-00790
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 3, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF LEAK ON THE ICY CATHETER (LOT # 160907) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT AT THE BOND. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. DRIED BLOOD RESIDUE WAS OBSERVED IN THE CATHETER'S BALLOONS AND LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION, AND NO ISSUES WERE OBSERVED. DURING FURTHER TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN GOOD START-UP KIT (SUK) AND RAN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A HIGH-SPEED RATE. A BOND LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON; THUS, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT # 160907.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT IVTM THERAPY FOR FEVER CONTROL. AN ICY CATHETER (LOT # 160907) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE TREATMENT WAS 39.0 °C, AND THE TARGET TEMPERATURE WAS SET AT 37.5 °C, ON FEVER CONTROL RATE. DURING THE COOLING PHASE OF THE TREATMENT, THE THERMOGARD CONSOLE (S/N (B)(4)) GENERATED AN "AIR TRAP" ALARM. FOLLOWING THE ALARM, THE USER NOTICED THAT THE 500-ML SALINE BAG WAS EMPTY. THE DWELL TIME OF THE CATHETER WAS 70 HOURS, AND THE PATIENT'S BODY TEMPERATURE WAS AT 37.6 °C WHEN THE ISSUE WAS NOTED. UPON INSPECTION, THERE WAS NO FLUID OBSERVED ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, OR ON THE FLOOR. THE CUSTOMER SUSPECTED A CATHETER LEAK AND INFUSION OF 250 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE CATHETER WAS NOT REPLACED, AND NO FURTHER INFORMATION WAS PROVIDED REGARDING THE DETAILS OF THE TREATMENT AND HOW IT WAS COMPLETED. AS REPORTED, THE CUSTOMER WAS UNABLE TO CLEAR THE "AIR TRAP" ALARM. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00854 FOR THE THERMOGARD CONSOLE (S/N (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318239 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 160907 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR