BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 6975763 · Received October 25, 2017

    Report

    Report Number
    3007899424-2017-00001
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    April 21, 2016
    Report Date
    June 15, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    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 DEVICE EXHIBITED WHAT APPEARED TO BE SIGNS OF BACTERIAL CONTAMINATION. NO PATIENT WAS INVOLVED OR AFFECTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEIR 3 HEATER COOLERS ARE DEVELOPING A PINK FILM IN THE WATER LINES COMING OUT OF THE COLD WATER TANK FOR THE CARDIOPLEGIA.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SUBMITTED ORIGINALLY IN (B)(6) 2017 UNDER GUIDANCE OF THE FDA AS A RETROACTIVE SUBMISSION. THIS ADVERSE EVENT IS BEING RESUBMITTED DUE TO ERRORS IN SECTION .

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) MEDICAL CENTER IN (B)(6) REPORTED THAT THEIR COOLER HEATER IS " DEVELOPING A PINK FILM IN THE WATER LINES COMNG OUT OF THE COLD WATER TAK FOR THE CARDIOPLEGIA." WE BELIEVE THIS PINK FILM TO BE EITHER SERRATIA MARCESCENS, METHYLOBACTERIA OR A SIMILAR BACTERIA THAT IS COMMONLY FOUND IN WATER SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755084 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown