BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 19530720 · Received June 13, 2024

    Report

    Report Number
    3007899424-2024-00081
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 13, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CQ SERVICE WAS NOTIFIED VIA MEDWATCH REPORT MW5154406, THAT THIS DEVICE WAS POTENTIALLY IDENTIFIED AS BEING CONTAMINATED DUE TO WATER SAMPLES THAT WERE COLLECTED AND TESTED BY THE CUSTOMER, RESULTING IN 507,000 MPN/ML, EXCEEDING THE <100 MPN/ML THRESHOLD FOR CONTAMINATION. FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDS THAT EITHER, (1) THE CUSTOMER REPERFORM CLEANING AND DISINFECTION PROCEDURES DETAILED IN THE IFU AND REPERFORM HPC TESTING, (2) HAVE THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT OR, (3) PARTICIPATE IN CARDIOQUIP'S TRADE IN PROGRAM. THE CUSTOMER CHOSE TO REPERFORM CLEANING AND DISINFECTION AND HPC TESTING. RESULTS AFTER CLEANING AND DISINFECTION WERE WITHIN CARDIOQUIP SPECIFICATIONS FOR WATER QUALITY, AND THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY.

    Description of Event or Problem · 0

    CQ SERVICE WAS NOTIFIED VIA MEDWATCH REPORT MW5154406, THAT THIS DEVICE WAS POTENTIALLY IDENTIFIED AS BEING CONTAMINATED DUE TO WATER SAMPLES THAT WERE COLLECTED AND TESTED BY THE CUSTOMER, RESULTING IN 507,000 MPN/ML, EXCEEDING THE <100 MPN/ML THRESHOLD FOR CONTAMINATION. THE DEVICES WERE SEQUESTERED WHEN POTENTIAL CONTAMINATION WAS FIRST IDENTIFIED, AND REMOVED FROM SERVICE ONCE WATER SAMPLE RESULTS WERE RECEIVED AND CONFIRMED BY THE CUSTOMER. THE CUSTOMER'S MEDWATCH REPORT STATES THAT THE CUSTOMER PERFORMED "SANITATION WITH MANUFACTURER'S APPROVED DISINFECTANT" AND TESTED THE WATER IN THE DEVICE AGAIN, AND RECEIVED UNSPECIFIED PASSING RESULTS WITHIN THE LIMIT OF <100 MPN/ML, AND THEN RECEIVED AN ANNUAL PREVENTIVE MAINTENANCE INSPECTION FROM CARDIOQUIP, WHICH WAS PERFORMED ON 04/16/2024, BEFORE THE DEVICE WAS RETURNED TO SERVICE. NO NOTE OF POTENTIAL DEVICE CONTAMINATION WAS MADE BY THE CARDIOQUIP TECHNICIANS DURING THEIR INSPECTION OF THE DEVICE. CQ RECEIVED MW5154406 ON 05/15/2024, NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795569 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown