BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM

    MDR report key: 11181474 · Received January 15, 2021

    Report

    Report Number
    1523658-2021-00026
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    June 29, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDSTM SITE WORKER HAD A POSITIVE DIAGNOSTIC TEST RESULT FOR SARS-COV-2. THE WORKER REPORTED MINOR SYMPTOMS. THE BATTELLE CCDS SITE WORKER WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) LEVEL 4 FULLY ENCAPSULATED PROTECTIVE SUIT WITH POSITIVE PRESSURE AND SELF-CONTAINED BREATHING APPARATUS WHILE HANDLING CONTAMINATED N95 RESPIRATORS. THEREFORE, THE CCDS SITE WORKER'S INFECTION IS NOT BEING ATTRIBUTED TO THE BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS. THE CCDS IS USED IN THE DECONTAMINATION OF COMPATIBLE N95 RESPIRATORS TO PREVENT EXPOSURE TO PATHOGENIC BIOLOGICAL AIRBORNE PARTICULATES. BECAUSE THE BATTELLE CCDS SITE WORKER IS REQUIRED, PURSUANT TO BATTELLE'S STANDARD OPERATING PROCEDURES, TO WEAR PPE LEVEL 4 FULLY ENCAPSULED PROTECTIVE SUIT WITH POSITIVE PRESSURE AND SELF-CONTAINED BREATHING APPARATUS WHILE HANDLING CONTAMINATED N95 RESPIRATORS, THE SITE WORKER WAS NOT WEARING A N95 RESPIRATOR THAT HAD BEEN REPROCESSED UNDER THE FDA'S EMERGENCY USE AUTHORIZATION (EUA) APPROVED MARCH 29, 2020, AND REVISED AND REISSUED ON JUNE 6, 2020. BATTELLE IS SUBMITTING THIS REPORT BECAUSE THE TERMS OF THE CCDS EUA AS INTERPRETED BY FDA REQUIRE REPORTING OF INFECTIONS AND POTENTIAL INFECTION OF BATTELLE PERSONNEL INVOLVED IN THE USE OF BATTELLE DECONTAMINATION SYSTEM. BATTELLE IS NOT AWARE OF INFORMATION TO SUGGEST THE CCDS OR A N95 RESPIRATOR HANDLED DURING THE DECONTAMINATION PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE CCDS SITE WORKER'S INFECTION.

    Description of Event or Problem · 1

    A BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS SITE WORKER HAD A POSITIVE DIAGNOSTIC TEST RESULT FOR SARS-COV-2. THE WORKER REPORTED MINOR SYMPTOMS. THE BATTELLE CCDS SITE WORKER WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) LEVEL 4 FULLY ENCAPSULATED PROTECTIVE SUIT WITH POSITIVE PRESSURE AND SELF-CONTAINED BREATHING APPARATUS WHILE HANDLING CONTAMINATED N95 RESPIRATORS. THEREFORE, THE CCDS SITE WORKER'S INFECTION IS NOT BEING ATTRIBUTED TO THE BATTELLE CRITICAL CARE DECONTAMINATION SYSTEM CCDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72373 BATTELLE CCDS CRITICAL CARE DECONTAMINATION SYSTEM DECONTAMINATION SYSTEMS FOR N95 RESPIRATORS QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1