BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 17356390 · Received July 19, 2023

    Report

    Report Number
    3007899424-2023-00266
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 19, 2023
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS OF TUBING WERE SUBMITTED BY A CARDIOQUIP TECHNICIAN AND SENT TO CARDIOQUIP EPIDEMIOLOGY FOR INVESTIGATION DURING AN ONSITE SERVICE VISIT. DUE TO THE DISCOLORATION OF THE TUBING, EPIDEMIOLOGY RECOMMENDED THAT THE DEVICE RECEIVE HPC TESTING TO PROVIDE A QUANTITATIVE ASSESSMENT OF THE WATER QUALITY. THE CUSTOMER WAS NOTIFIED OF THE POTENTIAL CONTAMINATION AND RECOMMENDATION VIA EMAIL ON (B)(6)2023. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE TO THE RECOMMENDATION OF REPAIR.

    Description of Event or Problem · 0

    CQ TECHNICIAN NOTIFIED CQ SERVICE VIA AIRTABLE THAT THE INTERNAL TUBING OF THIS DEVICE WAS FOUND TO BE POTENTIALLY CONTAMINATED DURING AN ON-SITE PM. THE TECHNICIAN TOOK PICTURES OF THE INTERNAL TUBING AND FORWARDED THEM TO CQ FOR REVIEW. CQ DIRECTOR OF OPERATIONS AND EPIDEMIOLOGIST MELANIE HARRY REVIEWED THE PICTURES, AND RECOMMENDED THAT THE DEVICE RECEIVE HPC TESTING TO GAIN A QUANTITATIVE ANALYSIS OF WATER QUALITY DUE TO THE VISIBLE DISCOLORATION WITHIN THE TUBING. THIS ISSUE WAS IDENTIFIED ON (B)(6)2023, NO PATIENT INVOLVEMENT WAS REPORTED. (NQA)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905243 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown