BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOQUIP MODULAR COOLER HEATER

    MDR report key: 12763366 · Received November 7, 2021

    Report

    Report Number
    3007899424-2021-00034
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 26, 2020
    Report Date
    June 13, 2022
    Manufacturer
    CARDIOQUIP, LLC
    Product Code
    DWC
    PMA / PMN Number
    K102147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CARDIOQUIP HAS NOT RECEVICED THE DEVICE. ONCE MORE INFORMATION HAS BEEN GATHERED, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    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 CUSTOMER SENT A COPY OF THE FDA MEDWATCH REPORT SENT BY THEM TO INFORM US OF AN ADVERSE EVENT. THE CUSTOMER CLAIMED THAT THE MCH WAS THE SOURCE OF THE CONTAMINATION. THE BACTERIA FOUND IN THE PATIENT WAS GENETICALLY SIMILAR TO THAT FOUND IN THE MCH. CARDIOQUIP WAS NOT ABLE TO TEST THE DEVICES AS THEY WERE RETIRED BUT COULD TEST OTHER DEVICES AT THE LOCATION. ONE OF THE UNITS CAME BACK POSITIVE AND ANOTHER CAME BACK NEGATIVE, RESULTING IN AN INCONCLUSIVE CAUSE OF THE ADVERSE EVENT.

    Description of Event or Problem · 0

    (B)(6) LEARNED THAT A CULTURE OBTAINED ON(B)(6) 2021 FROM THE STERNAL INCISION OF A CARDIAC TRANSPLANT PATIENT RESULTED FOR M ABSCESSUS. THE PATIENT HAD RECEIVED A HEART TRANSPLANT AT (B)(6) ON I (B)(6) 2020 FACILITATED BY A CARDIOQUIP MCH DEVICE DESIGNATED "UNIT F" BY (B)(6). CULTURES FROM THE PATIENT AND THE MCH UNIT WERE COLLECTED FOR ADDITIONAL ANALYSIS. IN THE INTERIM, (B)(6) REVIEWED IN DETAIL RECORDS RELATED TO TRAINING OF LICENSED PERFUSIONISTS AND THE CLEANING/DISINFECTION PROCEDURES FOR THE FACILITY'S MCH UNITS. THAT REVIEW REVEALED THAT (B)(6) PROCEDURES ADHERED TO AND, IN MANY ASPECTS EXCEEDED THE PROCESSES SET FORTH IN THE CARDIOQUIP IFUS. (B)(6) EXTRA PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: 1. IN ADDITION TO THE USE OF 0.2 ¿M FILTER TO PROVIDE DEMINERALIZED FILTERED WATER AS RECOMMENDED BY THE IF US, (B)(6) ALSO USES A PREFILTER AHEAD OF THE 0.2 ¿M FILTER. 2. ON A ROUTINE MONTHLY BASIS, (B)(6) DRAINS ALL WATER FROM THE UNITS AND DISINFECTS THE WATER TANKS MONTHLY, AS OPPOSED TO THE QUARTERLY BASIS SUGGESTED BY THE MANUFACTURER. DURING THIS PROCESS, IN ADDITION TO THE CLEANING AND DISINFECTION STEPS OUTLINED IN THE MANUFACTURER'S IFUS, (B)(6) ALSO LIFTS THE CONDENSER UNIT OUT FOR ADDITIONAL CLEANING. 3. (B)(6) PROVIDES TRAINING FOR LICENSED PERFUSIONISTS TO CONDUCT THE PERIODIC CLEANING AND DISINFECTION PROCEDURES OF THE MCH UNITS. INITIAL AND ANNUAL COMPETENCIES ARE DOCUMENTED AND REVIEWED BY A SUPERVISOR. 4. (B)(6) CONDUCTS MULTI-DISCIPLINARY REVIEWS TO KEEP UP-TO-DATE ON LITERATURE AND/OR ADVERSE EVENT REPORTS RELATED TO HEATER-COOLER MACHINES AND TO REVIEW ITS OWN PROCESSES AND DOCUMENTATION. (B)(6) REVIEW ESTABLISHED THAT ITS CLEANING, DISINFECTION, AND MAINTENANCE OF MCH UNIT F MET AND/OR EXCEEDED THE CARDIOQUIP IFUS AT ALL RELEVANT TIMES. (B)(6) SAMPLED MCH UNIT F AND CULTURES FROM TWO LOCATIONS GREW M ABSCESSUS. BECAUSE THE ORGANISM IS UBIQUITOUS IN THE ENVIRONMENT, (B)(6) SENT SAMPLES FROM UNIT F AND PATIENT CULTURES TO UNIVERSITY OF TEXAS MEDICAL CENTER-TYLER FOR GENOMIC ANALYSIS. ON (B)(6) 2021, (B)(6) RECEIVED RESULTS FROM THE LABORATORY DEMONSTRATING A GENETIC MATCH BETWEEN THE SAMPLES. A RECORDS REVIEW HAS REVEALED NO OTHER KNOWN M ABSCESSUS CASES AMONG 128 SURGICAL PATIENTS EXPOSED TO UNIT F BETWEEN (B)(6) 2020 AND THE DATE THE UNIT WAS REMOVED FROM SERVICE. AN EPIDEMIOLOGICAL INVESTIGATION CONFIRMED MCH UNIT F AS THE MOST LIKELY SOURCE OF THE PATIENT'S EXPOSURE. GENETICALLY SIMILAR M. ABSCESSUS COLONIES WERE NOT ISOLATED FROM ENVIRONMENTAL CULTURES TAKEN FROM THE ROOM WHERE THE PATIENT UNDERWENT THE TRANSPLANT SURGERY.

    Description of Event or Problem · 0

    (B)(6) HOSPITAL ("(B)(6)") LEARNED THAT A CULTURE OBTAINED ON (B)(6) 2021 FROM THE STERNAL INCISION OF A CARDIAC TRANSPLANT PATIENT RESULTED FOR M ABSCESSUS. THE PATIENT HAD RECEIVED A HEART TRANSPLANT AT (B)(6) ON I (B)(6) 2020 FACILITATED BY A CARDIOQUIP MCH DEVICE DESIGNATED "UNIT F" BY (B)(6). CULTURES FROM THE PATIENT AND THE MCH UNIT WERE COLLECTED FOR ADDITIONAL ANALYSIS. IN THE INTERIM, (B)(6) REVIEWED IN DETAIL RECORDS RELATED TO TRAINING OF LICENSED PERFUSIONISTS AND THE CLEANING/DISINFECTION PROCEDURES FOR THE FACILITY'S MCH UNITS. THAT REVIEW REVEALED THAT (B)(6)'S PROCEDURES ADHERED TO AND, IN MANY ASPECTS EXCEEDED THE PROCESSES SET FORTH IN THE CARDIOQUIP IFUS. (B)(6)'S EXTRA PROCEDURES INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: 1. IN ADDITION TO THE USE OF 0.2 [?]M FILTER TO PROVIDE DEMINERALIZED FILTERED WATER AS RECOMMENDED BY THE IF US, (B)(6) ALSO USES A PREFILTER AHEAD OF THE 0.2 [?]M FILTER. 2. ON A ROUTINE MONTHLY BASIS, (B)(6) DRAINS ALL WATER FROM THE UNITS AND DISINFECTS THE WATER TANKS MONTHLY, AS OPPOSED TO THE QUARTERLY BASIS SUGGESTED BY THE MANUFACTURER. DURING THIS PROCESS, IN ADDITION TO THE CLEANING AND DISINFECTION STEPS OUTLINED IN THE MANUFACTURER'S IFUS, (B)(6) ALSO LIFTS THE CONDENSER UNIT OUT FOR ADDITIONAL CLEANING. 3. (B)(6) PROVIDES TRAINING FOR LICENSED PERFUSIONISTS TO CONDUCT THE PERIODIC CLEANING AND DISINFECTION PROCEDURES OF THE MCH UNITS. INITIAL AND ANNUAL COMPETENCIES ARE DOCUMENTED AND REVIEWED BY A SUPERVISOR. 4. (B)(6) CONDUCTS MULTI-DISCIPLINARY REVIEWS TO KEEP UP-TO-DATE ON LITERATURE AND/OR ADVERSE EVENT REPORTS RELATED TO HEATER-COOLER MACHINES AND TO REVIEW ITS OWN PROCESSES AND DOCUMENTATION. (B)(6)'S REVIEW ESTABLISHED THAT ITS CLEANING, DISINFECTION, AND MAINTENANCE OF MCH UNIT F MET AND/OR EXCEEDED THE CARDIOQUIP IFUS AT ALL RELEVANT TIMES. (B)(6) SAMPLED MCH UNIT F AND CULTURES FROM TWO LOCATIONS GREW M ABSCESSUS. BECAUSE THE ORGANISM IS UBIQUITOUS IN THE ENVIRONMENT, (B)(6) SENT SAMPLES FROM UNIT F AND PATIENT CULTURES TO UNIVERSITY OF TEXAS MEDICAL CENTER-TYLER FOR GENOMIC ANALYSIS. ON (B)(6), 2021, (B)(6) RECEIVED RESULTS FROM THE LABORATORY DEMONSTRATING A GENETIC MATCH BETWEEN THE SAMPLES. A RECORDS REVIEW HAS REVEALED NO OTHER KNOWN M ABSCESSUS CASES AMONG 128 SURGICAL PATIENTS EXPOSED TO UNIT F BETWEEN (B)(6) 2020 AND THE DATE THE UNIT WAS REMOVED FROM SERVICE. AN EPIDEMIOLOGICAL INVESTIGATION CONFIRMED MCH UNIT F AS THE MOST LIKELY SOURCE OF THE PATIENT'S EXPOSURE. GENETICALLY SIMILAR M. ABSCESSUS COLONIES WERE NOT ISOLATED FROM ENVIRONMENTAL CULTURES TAKEN FROM THE ROOM WHERE THE PATIENT UNDERWENT THE TRANSPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657789 CARDIOQUIP MODULAR COOLER HEATER CARDIOPULMONARY BYPASS DEVICE DWC CARDIOQUIP, LLC MCH-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention| H