BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL QUATTRO EU CATHETER

    MDR report key: 7871396 · Received September 12, 2018

    Report

    Report Number
    3010617000-2018-00924
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 20, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A QUATTRO CATHETER SLOW COOLING WAS CONFIRMED DURING VISUAL INSPECTION. A KINK WAS FOUND ON THE SHAFT AT 10 CM AWAY FROM THE DISTAL END OF MANIFOLD. A KINK ON THE CATHETER CAN CAUSE A RESTRICTION OF FLUID FLOW AND IMPACT THE COOLING TREATMENT. INITIAL FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL 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. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. NO LEAK WAS OBSERVED. ALL LUMENS FLUSHED AS INTENDED. DURING MANUFACTURING ALL CATHETERS ARE 100% INSPECTED FOR VISUAL INSPECTION. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. THE EXACT TIMING AND CAUSE OF THE KINKED ON THE CATHETER CANNOT BE DETERMINED. PROBABLE CAUSE FOR THE KINKED CATHETER IS USER MISHANDLING. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 80871.

    Additional Manufacturer Narrative · 1

    THE ZOLL CATHETER WAS RETURNED TO ZOLL ON 08/32018 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

    CUSTOMER REPORTED THAT DURING PATIENT THERAPY FOR HYPOTHERMIA, SLOW COOLING WAS OBSERVED, NOT REACHING TARGET TEMPERATURE OF 34°C WITHIN 12 HOURS. SMOOTH INSERTION OF THE QUATTRO CATHETER (LOT NUMBER 80871) THROUGH THE PATIENT'S LEFT FEMORAL. SET TEMPERATURE STARTED AT 36.5°C AND AFTER 96 HOURS (4 DAYS) OF DWELL TIME AT MAX RATE, TEMPERATURE REACHED AT 36.3°C. THE CUSTOMER DID NOT PERFORM ANY OTHER TEMPERATURE MANAGEMENT PROCEDURES. NO SYSTEM ALARM NOTICED AND NO FLUID LEAK WERE OBSERVED. HENCE, NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709961 ZOLL QUATTRO EU CATHETER CENTRAL VENOUS START UP KIT NCX ZOLL CIRCULATION IC-4593AE 80871 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1