BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 18252380 · Received December 1, 2023

    Report

    Report Number
    3007899424-2023-00467
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 1, 2023
    Report Date
    July 26, 2024
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO SUSPECTED CONTAMINATION A CUSTOMER COMPLETED HETEROTROPHIC PLATE COUNT ON WATER FROM THEIR DEVICE TO QUANTITATIVELY ASSESS WATER QUALITY. TEST RESULTS WERE OUTSIDE OF CARDIOQUIP'S ACCEPTABLE LIMITS. THIS INFORMATION WAS RELAYED TO THE CUSTOMER VIA EMAIL ON (B)(6) 2023. ALONG WITH THIS THE CUSTOMER WAS INFORMED THAT THEY COULD EITHER COMPLETE AN INTERNAL WATER PATHWAY REPLACEMENT ON THEIR DEVICE TO RETURN IT TO SPECIFICATION OR PARTICIPATE IN CARDIOQUIP'S TRADE-IN PROGRAM. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE TO THESE RECOMMENDATIONS. A FOLLOW-UP WILL BE FILED IF ANY ADDITIONAL INFORMATION OR INFORMATION THAT CORRECTS THIS REPORT IS OBTAINED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

    FOLLOWING HPC TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE CUSTOMER THEN SENT THE DEVICE TO CARDIOQUIP FOR REPAIR. THE DEVICE WAS RETURNED TO SPECIFICATION VIA AN INTERNAL WATER PATHWAY REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.

    Description of Event or Problem · 0

    LAB RESULTS((B)(6) 2023): 11161635 - >1,146,000 MPN/ML (ABOVE ACCEPTABLE LIMIT). TO REMEDIATE THE DEVICE CONTAMINATION, THE CUSTOMER EITHER PROCEED WITH AN INTERNAL WATER PATH REPLACEMENT PROCEDURE OR A TRADE-IN PROGRAM.

    Description of Event or Problem · 0

    LAB RESULTS (ON (B)(6) 2023): (B)(6) >1,146,000 MPN/ML (ABOVE ACCEPTABLE LIMIT). TO REMEDIATE THE DEVICE CONTAMINATION, THE CUSTOMER EITHER PROCEED WITH AN INTERNAL WATER PATH REPLACEMENT PROCEDURE OR A TRADE-IN PROGRAM.

    Description of Event or Problem · 0

    LAB RESULTS(B)(6) 2023): 11161635 - >1,146,000 MPN/ML (ABOVE ACCEPTABLE LIMIT). TO REMEDIATE THE DEVICE CONTAMINATION, THE CUSTOMER EITHER PROCEED WITH AN INTERNAL WATER PATH REPLACEMENT PROCEDURE OR A TRADE-IN PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592314 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(M)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown