BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14744970 · Received June 20, 2022

    Report

    Report Number
    3007899424-2022-00018
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    July 28, 2021
    Report Date
    June 8, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 UNIT WAS PRODUCING A "SMELLY WHITE FLUID". NO ADDITIONAL INVESTIGATION IS AVAILABLE AS THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION REGARDING THIS ISSUE AFTER MULTIPLE ATTEMPTS FOR FOLLOW-UP.

    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. CUSTOMER REPORTED 11 INSTANCES OF PATIENT STERNAL INFECTIONS. THERE WERE 5 DEVICES USED AMONG THE 11 SURGERIES. ONE DEVICE THAT WAS USED IN 4 OF THE SURGERIES WAS TESTED FOR MICROBIAL CONTAMINATION ALONG WITH A DEVICE NOT USED IN ANY OF THE SURGERIES. THE SAMPLE CONTAMINATION LEVELS WERE NOTED AS "FEW" AND "MANY". THE CUSTOMER NOTED THAT THE STRAINS FOUND WERE NOT RELATED TO THOSE FOUND IN THE PATIENTS; THEREFORE, THE MICROBIAL CONTAMINATION OF THE DEVICE WAS NOT DIRECTLY LINKED TO THE INFECTION. ADDITIONALLY, THE CUSTOMER REPORTED THAT THEY IDENTIFIED ENVIRONMENTAL ISSUES CONTRIBUTING TO THE CONTAMINATION OF THE DEVICE DESPITE FOLLOWING THE IFU FOR PERIODIC DISINFECTION AND THE USE OF MICROBIAL WATER FILTER.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THEIR DEVICE IS PRODUCING A "SMELLY WHITE FLUID" WHILE NOT IN USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ELEVEN PATIENTS DEVELOPED PSEUDOMONAS AERUGINOSA STERNAL SURGICAL SITE INFECTION. FIVE DIFFERENT DEVICES WERE USED FOR THESE ELEVEN CARDIAC SURGERIES. THE WATER RESERVOIR OF ONE OF THE DEVICES USED FOR FOUR OF THE ELEVEN PROCEDURE AND ONE ADDITIONAL DEVICE NOT USED FOR ANY OF THE ELEVEN PROCEDURES BOTH GREW P. AERUGINOSA. THE MICROBIAL CONTAMINATION OF THE DEVICES IS NOT DIRECTLY LINKED TO THE OUTBREAK OF CARDIAC SSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157474 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown