BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 12663211 · Received October 20, 2021

    Report

    Report Number
    3010617000-2021-00962
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 17, 2020
    Report Date
    November 18, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075213
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COOL LINE CATHETER ISSUE WAS CONFIRMED BASED ON VISUAL INSPECTION. THE MEDIAL LUERED TUBING WAS TORN/RUPTURED AS RECEIVED. PROBABLE CAUSES FOR THE REPORTED COMPLAINT WAS DUE TO THE HIGH-PRESSURE INTRODUCTION CAUSED BY THE USE OF A HIGH-PRESSURE PUMP. COOL LINE CATHETER INSTRUCTIONS FOR USE WARN AGAINST USING PRESSURE EXCEEDING 100 PSI. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND THE MEDIAL INFUSION PORT WAS CLAMPED AND TIED AS A KNOT. AFTER THE KNOT WAS REMOVED, THE TUBING WAS OBSERVED TORN, RUPTURED, AND SPLIT INTO TWO. THE TEAR WAS MEASURED 2CM, LOCATED AT THE DISTAL END OF MEDIAL LUER DUE TO THE HIGH-PRESSURE INTRODUCTION LIKELY CAUSED BY THE USE OF THE HIGH-PRESSURE PUMP DURING THE CONTRAST AGENTS INJECTION. NOTICED BLOOD RESIDUE IN THE MEDIAL LUERED TUBING. NO OTHER PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. THE DISTAL AND PROXIMAL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, THE BALLOONS FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI WITHOUT ANY ISSUES. NO LEAK WAS OBSERVED. THE BALLOONS DID NOT LEAK DURING TESTING. 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 COOL LINE CATHETER WITH LOT NUMBER 160832.

    Description of Event or Problem · 0

    THE DECEASED ORGAN DONOR WAS ADMITTED FOR A MULTI-ORGAN HARVEST. ZOLL COOL LINE CATHETER (LOT # 160832) WAS INSERTED IN THE RIGHT INTERNAL JUGULAR VEIN BY A PHYSICIAN SMOOTHLY, AT THE FIRST ATTEMPT. THE COOL LINE CATHETER WITH THE THERMOGARD CONSOLE WAS USED FOR 3 HOURS FOR IVTM THERAPY DURING THE PATIENT PREPARATION FOR A CT SCAN WITH THE APPLICATION OF SODIUM CHLORIDE (NACL) VEIN GUARD SOLUTION THROUGH ONE OF THE COOL LINE CATHETER INFUSION PORTS. THE BAYER MEDRAD INJECTOR HIGH-PRESSURE PUMP WAS USED TO ADMINISTER THE CONTRAST AGENTS THROUGH THE MEDIAL INFUSION PORT OF THE COOL LINE CATHETER AT THE 3CC/SECOND RATE. A TOTAL OF 90CC OF CONTRAST MEDIUM WERE INJECTED. THE MEDIAL INFUSION PORT TUBING BURST NEXT TO THE MEDIAL LUER DURING THE INJECTION OF THE CONTRAST FLUID. TO REDUCE THE RISK OF PULMONARY EMBOLISM, THE INFUSION LINE WAS CLAMPED AND UPON RETURN TO THE INTENSIVE CARE UNIT, THE KNOT WAS TIED AND A PLUG WAS FITTED TO THE LINE. FOLLOWING THIS, THE COOL LINE CATHETER WAS REPLACED AND THE REGULAR CENTRAL VENOUS CATHETER (CVC) LINE WAS PLACED. THE CUSTOMER STATED THAT THE CATHETER'S MEDIAL LUMEN DID NOT RESIST TO THE PRESSURE DURING THE INJECTION OF THE CONTRAST PRODUCT AND THE MEDIAL TUBING SPLIT INTO TWO JUST BELOW THE LUER.

    Additional Manufacturer Narrative · 1

    THE ZOLL COOL LINE CATHETER WAS NOT RETURNED TO ZOLL FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A MULTI-ORGAN HARVEST. ZOLL COOL LINE CATHETER (LOT #161437) WAS INSERTED BY A PHYSICIAN SMOOTHLY, AT THE FIRST ATTEMPT. THE COOL LINE CATHETER WAS UTILIZED DURING THE PATIENT PREPARATION FOR A CT SCAN. THE HIGH-PRESSURE PUMP WAS USED TO ADMINISTER THE CONTRAST AGENTS THROUGH THE DISTAL INFUSION PORT OF THE COOL LINE CATHETER. THE DISTAL INFUSION PORT TUBING BURST NEXT TO THE DISTAL LUER AFTER THE USER APPLIED THE CONTRAST FLUID. TO REDUCE THE RISK OF PULMONARY EMBOLISM, THE INFUSION LINE WAS CLAMPED AND UPON RETURN TO THE INTENSIVE CARE UNIT, THE KNOT WAS TIED AND A PLUG WAS FITTED TO THE LINE. FOLLOWING THIS, THE COOL LINE CATHETER WAS REPLACED AND THE REGULAR CENTRAL VENOUS CATHETER (CVC) LINE WAS PLACED. THE CUSTOMER STATED THAT THE CATHETER'S DISTAL LUMEN DID NOT RESIST TO THE PRESSURE DURING THE INJECTION OF THE CONTRAST PRODUCT AND THE DISTAL TUBING SPLIT IN TO TWO JUST BELOW THE LUER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562096 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295AE 160832 00849111075213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown