BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELERITY 20 HP BIOLOGICAL INDICATOR

    MDR report key: 10451441 · Received August 25, 2020

    Report

    Report Number
    3004080920-2020-00001
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 25, 2020
    Manufacturer
    STERIS CORPORATION
    Product Code
    QKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE N95 RESPIRATORS SUBJECT OF THE CYCLE WERE DISCARDED. A STERIS ACCOUNT MANAGER ARRIVED ONSITE AND SPOKE WITH USER FACILITY PERSONNEL REGARDING THE REPORTED EVENT AND IDENTIFIED THAT USER FACILITY PERSONNEL WERE NOT FOLLOWING THE PARAMETERS OF THE EMERGENCY USE AUTHORIZATION (EUA) FOR THE EMERGENCY USE OF THE ADVANCED STERILIZATION PRODUCTS, INC. (ASP) STERRAD 100S, NX, AND 100NX STERILIZATION SYSTEMS2 FOR USE IN DECONTAMINATING COMPATIBLE N95 RESPIRATORS APPROVED JUNE 6, 2020. THE USER FACILITY DECONTAMINATED THE N95 RESPIRATOR'S SUBJECT OF THIS EVENT 20 TIMES; HOWEVER, THE EUA INDICATES THAT EACH RESPIRATOR SHOULD NOT EXCEED TWO (2) DECONTAMINATION CYCLES. ADDITIONALLY, THE CELERITY 20 HP BI IS NOT THE AUTHORIZED BIOLOGICAL INDICATOR TO UTILIZE WITH THE STERRAD 100NX SYSTEM PER THE EUA; INSTEAD A VELOCITY BIOLOGICAL INDICATOR/PROCESS CHALLENGE DEVICE MUST BE USED. THE ACCOUNT MANAGER NOTIFIED USER FACILITY PERSONNEL THAT DECONTAMINATING MASKS 20 TIMES AND USE OF THE CELERITY 20 HP BI DO NOT MEET THE AUTHORIZED PARAMETERS OF THE EUA. STERIS IS NOT THE MANUFACTURER OF THE STERRAD 100NX SYSTEM; STERIS NOTIFIED THE MANUFACTURER, STERRAD, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY. DURING A CALL BETWEEN A STERIS SENIOR DIRECTOR, REGULATORY AFFAIRS, AND FDA ON JUNE 6, 2020, THE AGENCY PROVIDED A LIST OF THE TYPES OF N95 EVENTS THAT SHOULD BE REPORTED UNDER THE EUA, INCLUDING: ALLERGIC REACTIONS; RESPIRATOR UNABLE TO PERFORM ESSENTIAL FUNCTIONS; DAMAGE TO ANY MATERIALS; ODOR DUE TO RESIDUALS; CONTACT TO RESIDUALS; INFECTION; TRENDS OF USERS; BIOLOGICAL INDICATOR FAILURES; AND MALFUNCTION OF A STERILIZER (SPECIFIC TO N95 CYCLE). ALTHOUGH THE USER FACILITY UTILIZED AN INCORRECT BI PER THE APPROVED EUA, STERIS IS REPORTING THIS EVENT BECAUSE OF THE REPORT OF A BIOLOGICAL INDICATOR EVIDENCING POSITIVE RESULTS FOLLOWING DECONTAMINATION OF N95 RESPIRATORS IN A STERRAD 100NX SYSTEM WHICH IS A TYPE OF EVENT UNDER THE EUA THAT IS REPORTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR CELERITY 20 HP BIOLOGICAL INDICATOR (BI) EVIDENCED POSITIVE RESULTS FOLLOWING DECONTAMINATION OF N95 RESPIRATORS IN THEIR STERRAD 100NX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916758 CELERITY 20 HP BIOLOGICAL INDICATOR CELERITY 20 HP BIOLOGICAL INDICATOR QKY STERIS CORPORATION 20210416, 21210418

    Patients

    Seq Age Sex Outcome Treatment
    1