BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER

    MDR report key: 20215423 · Received September 13, 2024

    Report

    Report Number
    3010617000-2024-00705
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 17, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM) AND H11 (PROVIDE NARRATIVE/ DATA) WERE CORRECTED. THE CATHETER LOT NUMBER LISTED IN THESE SECTIONS WAS INCORRECT. THE REPORTED COMPLAINT OF A LEAK IN THE QUATTRO CATHETER (LOT 195871) WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE CATHETER. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THE QUATTRO CATHETER WITH LOT 195871.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK IN THE QUATTRO CATHETER (LOT 195781) WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE CATHETER. A WATER EMISSION, LEAK WAS OBSERVED FROM THE PROXIMAL LUER PORT AND AT THE PROXIMAL INFUSION LUMEN OPENING DURING THE LUMEN CROSSTALK TEST. THE PROBABLE ROOT CAUSE IS A WEAKENED WALL BETWEEN THE LUMENS, WHICH WITHSTOOD PRESSURE TESTING DURING MANUFACTURING BUT RESULTED IN A LEAK DURING CLINICAL USE. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. BLOOD RESIDUE WAS OBSERVED IN THE LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL THE INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO LEAK WAS OBSERVED FROM THE CATHETER BALLOONS. HOWEVER, A WATER EMISSION, LEAK WAS OBSERVED FROM THE PROXIMAL LUER PORT AND AT THE PROXIMAL INFUSION LUMEN OPENING DURING THE LUMEN CROSSTALK TEST, CONFIRMING THE REPORTED COMPLAINT. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THE QUATTRO CATHETER WITH LOT 195781.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IVTM THERAPY USING QUATTRO CATHETER (LOT 195871) BEGAN.

    Description of Event or Problem · 0

    ON 8/16/2024, IVTM THERAPY USING QUATTRO CATHETER (LOT 195781) BEGAN. ON THE SECOND DAY OF TREATMENT, THE MEDICAL DOCTOR NOTICED THAT THE SALINE WAS DECREASING, SO THE MEDICAL DOCTOR REPLACED THE SALINE BAG WITH A NEW ONE AND CONTINUED TREATMENT. HOWEVER, AS THE AMOUNT OF SALINE CONTINUED TO DECREASE GRADUALLY, THE CATHETER WAS REMOVED ON (B)(6) 2024 AND TREATMENT WAS TERMINATED. THE CUSTOMER REQUESTED AN INVESTIGATION AS THE SALINE HAD DECREASED AND THE BALLOON MAY HAVE BEEN DAMAGED, CAUSING THE SALINE TO LEAK. THE DWELL TIME WAS OVER 48 HOURS. NO ALTERNATE THERAPY WAS STARTED. NO DEVICE MALFUNCTION OF THE START-UP KIT WAS REPORTED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208125 QUATTRO® JAPAN, INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN CUSTOM LUER INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC IC-4593 195871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown