BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 11355218 · Received February 19, 2021

    Report

    Report Number
    3010617000-2021-00192
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 21, 2021
    Report Date
    March 22, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075527
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IN H4: UPDATED THE MANUFACTURING DATE. THE REPORTED COMPLAINT ABOUT THE ICY CATHETER (LOT # 151375) LEAK AND CRACKED IN-LUER WAS CONFIRMED DURING VISUAL INSPECTION AND FUNCTIONAL TESTING. THE PROBABLE ROOT CAUSE FOR THE CRACKED LUER COULD BE DUE TO A LATENT MATERIAL DEFECT OR DUE TO OVER TORQUEING OF THE LUER. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND THE "IN" LUER LOCK CONNECTION WAS CRACKED. NOTICED BLOOD RESIDUES IN THE DISTAL LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE RETURNED CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE AND UPON PRESSURIZING THE CATHETER, A WATER/EMISSION/LEAK WAS OBSERVED AT THE "IN" LUER LOCK CONNECTION; 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 INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THE ICY CATHETERS WITH LOT # 151375.

    Additional Manufacturer Narrative · 1

    THE ICY CATHETER (LOT# 150505) IN COMPLAINT WAS RETURNED TO ZOLL ON 09 FEBRUARY 2021 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    APPROXIMATELY 9 HOURS AFTER THE INITIATION OF THE IVTM THERAPY, THE NURSE OBSERVED THAT THE SALINE BAG DECREASED AND BED SHEET WAS WET. FOLLOWING THIS, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) AND START-UP KIT WAS REPLACED. AFTER 5 HOURS AND 32 MINUTES, AGAIN SALINE LEAK WAS OBSERVED. THE USER REPLACED THE ICY CATHETER AND SUK. IT WAS OBSERVED THAT THERE WAS A CRACK ON THE INFLOW LEUR OF THE ICY CATHETER (LOT# 150505) . NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REOPRT: MFR # 3010617000-2021-00198 FOR THE THERMOGARD XP IVTM SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245457 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 150505 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1