BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOQUIP MODULAR COOLER-HEATER

    MDR report key: 12381014 · Received August 27, 2021

    Report

    Report Number
    3007899424-2021-00018
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    May 14, 2021
    Report Date
    August 27, 2021
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MW5102484 RECEIVED IN THE MAIL ON JULY 27, 2021 STATING THE FOLLOWING: MICROBIAL CONTAMINATION OF HEATER COOLER DEVICE WATER RESERVOIRS POTENTIALLY CONTRIBUTING TO CARDIAC SURGICAL SITE INFECTIONS. ELEVEN PATIENTS DEVELOPED PSEUDOMONAS AERUGINOSA STERNAL SURGICAL SITE INFECTION (SSI) A MEDIAN OF 24 DAYS (RANGE, 11-54 DAYS) AFTER UNDERGOING MEDIAN STERNOTOMY INCISION WITH USE OF CARDIOPULMONARY BYPASS WITH THE CARDIOQUIP HEATER COOLER DEVICE FOR VALVE REPLACEMENT (N=7) OR CABG (N=4) CARDIAC SURGICAL PROCEDURES. FIVE DIFFERENT CARDIOQUIP MCH-1000(I) DEVICES WERE UTILIZED FOR THESE 11 CARDIAC SURGERIES. THE WATER RESERVOIR OF ONE OF THE HEATER COOLER DEVICES USED FOR 4 OF THE 11 PROCEDURES AND ONE ADDITIONAL HEATER COOLER DEVICE NOT USED FOR ANY OF THE 11 PROCEDURES BOTH GREW P. AERUGINOSA. THE HEATER COOLER DEVICES HAD BEEN MAINTAINED AND CLEANED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS FOR USE. BOTH THE ICE MACHINES AND THE POTABLE WATER USED TO FILL AND CLEAN THE WATER RESERVOIRS USED 0.2 MICRON MICROBIOLOGIC FILTERS. NINE AVAILABLE PATIENT AND 3 ENVIRONMENTAL P. AERUGINOSA ISOLATES WERE SENT OUT FOR WHOLE GENOME SEQUENCING (WGS) ANALYSIS TO ASSESS STRAIN RELATEDNESS. WGS ANALYSIS DEMONSTRATED THAT 8 OF 9 PATIENT ISOLATES WERE THE SAME STRAIN TYPE, WHEREAS NONE OF 3 ENVIRONMENTAL ISOLATES WERE RELATED TO ANY OF THE PATIENT ISOLATES OR EACH OTHER. THEREFORE, THE MICROBIAL CONTAMINATION OF THE HEATER COOLER DEVICES IS NOT DIRECTLY LINKED TO THE OUTBREAK OF CARDIAC SSI. FOLLOWING MODIFICATION OF THE PROCEDURES FOR INTRAOPERATIVE USE AND CLEANING OF THE CARDIOQUIP DEVICES, NO ADDITIONAL CASES OF P. AERUGINOSA SSI HAVE BEEN IDENTIFIED AMONG PATIENTS UNDERGOING CARDIAC SURGERY PROCEDURES. THERAPY DATES: (B)(6) 2021. FDA SAFETY REPORT ID# (B)(4). FOLLOW-UP WITH THE CUSTOMER IDENTIFIED A TOTAL OF 11 PATIENTS WERE INVOLVED WITH THIS MEDWATCH REPORT. A SEPARATE REPORT IS BEING FILED FOR EACH PATIENT, HOWEVER CUSTOMER WAS UNABLE TO PROVIDE 2 SERIAL NUMBERS. CARDIOQUIP'S REVIEW, BASED ON THE INFORMATION DESCRIBED IN THE USER FACILITY MEDWATCH REPORT (MW5102484), THE INFORMATION DESCRIBES THAT THE PATIENT ISOLATES AND ENVIRONMENTAL ISOLATES ARE NOT RELATED THUS INDICATING THAT THE HEATER-COOLER USED DURING THE PATIENT'S SURGERY IS NOT DIRECTLY LINKED TO THE PATIENT'S INFECTION. THIS IS SUPPORTED BY THE WHOLE GENOME SEQUENCING (WGS) THAT DAVID PEGUES (MEDICAL DIRECTOR OF HEALTHCARE EPIDEMIOLOGY) REPORTED WAS CONDUCTED IN THE USER FACILITY MEDWATCH REPORT.

    Description of Event or Problem · 1

    (B)(6) 2021 S/P AVR, AORTIC HEMIARCH REPAIR. DEVELOPED STERNAL SURGICAL SITE INFECTION (OSTEOMYELITIS, MEDIASTINITIS) WITH P. AERUGINOSA (B)(6) 2021. REQUIRED STERNAL DEBRIDEMENT, MEDIASTINAL WASH OUT, PECTORALIS FLAPS AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277207 CARDIOQUIP MODULAR COOLER-HEATER CARDIOPLUMONARY BYPASS COOLER HEATER DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention