BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 14739191 · Received June 17, 2022

    Report

    Report Number
    3007899424-2022-00012
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    April 14, 2021
    Report Date
    April 22, 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 SPOTTED TUBING IS A RESULT FROM LANKENAU MEDICAL CENTER'S CONTAMINATED WATER SYSTEM. THE SPOTTED TUBING WAS SENT TO CARDIOQUIP FROM LANKENAU MEDICAL CENTER, FOR TESTING. A SWAB SAMPLE WAS TAKEN OF THE TUBING AND FOUND 200 CFU/SWAB OF M. FRANKLINII. CARDIOQUIP CONDUCTED TESTING AT LANKENAU MEDICAL CENTER AND SAMPLED VARIOUS DEVICES, SOURCE WATER, ICE MACHINE, AND COOLERS. THE LAB REPORTS INDICATED THE SAME MYCOBACTERIUM, M. FRANKLINII, WAS ALSO FOUND TO BE A CONTAMINANT WITHIN THEIR SOURCE WATER, IN WHICH THEY USED TO FILL UP THEIR HEATER-COOLERS. THE SPOTTED TUBING WAS USED ON DEVICE SERIAL NUMBER (B)(4) AND THAT DEVICE ALSO TESTED POSITIVE FOR M. FRANKLINII.

    Description of Event or Problem · 0

    CUSTOMER REPORTS THAT THE ANTIMICROBIAL TUBING OF THEIR HEATER COOLERS HAS DEVELOPED DARK SPOTS OR BLOTCHES, AND THEY ARE VERY CONFUSED AS TO WHY THIS IS OCCURRING. THE CUSTOMER SAYS THEY USE BLEACH AS A PRIMARY DISINFECTANT, PERFORM CLEANINGS AT LEAST QUARTERLY AND THAT THEIR FACILITY USES WATER WHICH HAS PASSED THROUGH A 0.2 MICRON FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189273 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown