BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 12763448 · Received November 7, 2021

    Report

    Report Number
    3007899424-2021-00038
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 12, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS REPORTING THE FOLLOWING COMPLAINT AFTER A VOLUNTARY REVIEW OF ALL COMPLAINTS (REPORTABLE OR NOT) SINCE 2016. THIS REPORT IS BEING FILED NOW, AFTER BEING SCRUTINIZED UNDER A NEWLY REVISED RISK MATRIX, RECENTLY ADOPTED AFTER INSPECTION. THE CUSTOMER NOTIFIED CARDIOQUIP THAT A PATIENT WAS INVOLVED DURING THE MALFUNCTION ALTHOUGH NO PATIENT INFORMATION WAS COMMUNICATED. CARDIOQUIP'S INVESTIGATION DETERMINED THAT THE DEVICE MALFUNCTION DESCRIBED BY THE CUSTOMER COULD NOT BE REPLICATED; HOWEVER, THE COOLING VALVE RELAY WAS REPLACED TO MITIGATE FUTURE DEVICE MALFUNCTION. FOLLOWING REPLACEMENT, THE DEVICE PASSED INSPECTION, AND IS FULLY OPERATIONAL.

    Additional Manufacturer Narrative · 0

    CARDIOQUIP HAS REACHED OUT TO (B)(6) MEDICAL CENTER MULTIPLE TIMES REGARDING RECEIVING THE DEVICE FOR AN INVESTIGATION AND REPAIR. BECAUSE THE DEVICE IS STILL IN USE ON A PATIENT, THEY ARE UNABLE TO SEND IT TO CARDIOQUIP. IF THE DEVICE IS RECEIVED, OR ANY ADDITIONAL INFORMATION IS MADE AVAILABLE, CARDIOQUIP WILL FILE ADDITIONAL REPORTS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THEIR DEVICE IS FAILING THE COOLING PORTION OF THE SELF-TEST WHILE IN USE ON PATIENTS. UPON FOLLOW-UP BY CQ SERVICE, THE CUSTOMER HAD THE DEVICE ON A PATIENT AND STATED THAT THE DEVICE WAS WORKING AS INTENDED AT THAT TIME.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THEIR DEVICE IS FAILING THE COOLING PORTION OF THE SELF-TEST WHILE IN USE ON PATIENTS. UPON FOLLOW-UP BY CQ SERVICE, THE CUSTOMER HAD THE DEVICE ON A PATIENT AND STATED THAT THE DEVICE WAS WORKING AS INTENDED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661343 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown