BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER 1-DR

    MDR report key: 11127506 · Received January 6, 2021

    Report

    Report Number
    2084725-2020-50312
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 17, 2020
    Report Date
    April 5, 2021
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    UDI-DI
    10705037014491
    PMA / PMN Number
    K071385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF MIST/HAZE ISSUE AND SYSTEM RISK ANALYSIS (SRA). THE DHR WAS REVIEWED AND NO ISSUES RELATING THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. TRENDING ANALYSIS OF THE MIST/HAZE ISSUE FOR THE STERRAD® 100NX UNIT WAS REVIEWED FOR THE PRIOR SIX MONTHS FROM OPEN DATE AND NO SIGNIFICANT TREND WAS OBSERVED. THE SRA SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." THE OIL MIST FILTER, CATALYTIC CONVERTER, MALE CONNECTOR, AND VACUUM PUMP OIL WERE NOT RETURNED FOR FURTHER EVALUATION. THE ASSIGNABLE CAUSE OF THE MIST/HAZE IS THE OIL MIST FILTER, CATALYTIC CONVERTER, MALE CONNECTOR, AND VACUUM PUMP OIL. THE FIELD SERVICE ENGINEER REPLACED THESE PARTS AND CONFIRMED THE STERRAD® 100NX WAS RESTORED TO PROPER FUNCTION AFTER SERVICE. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: (B)(4).

    Additional Manufacturer Narrative · 0

    D10: DEVICE AVAILABLE FOR EVALUATION: CORRECTION FROM NO TO YES G5: PMA/510(K): CORRECTION: IT WAS ORIGINALLY REPORTED IN THE INITIAL MEDWATCH REPORT THE PMA/501(K) NUMBER AS K991999. THE CORRECTED NUMBER IS K071385 AND WAS ADDED TO THE SUPPLEMENTAL (1) MEDWATCH ON 4/1/2021. IT WAS ORIGINALLY REPORTED THE PARTS WERE NOT RETURNED FOR ANALYSIS AND FURTHER EVALUATION. HOWEVER, ON 3/31/2021, THE OIL MIST FILTER, CATALYTIC CONVERTER AND MALE CONNECTOR WERE RETURNED FOR ANALYSIS. THE OIL MIST FILTER AND CATALYTIC CONVERTER SUCCESSFULLY COMPLETED A TEST CYCLE WITH NO FAILURES OR FAULTS. THERE WAS NO MIST, ODOR, SMELLS, VAPOR, SMOKE OR OIL LEAKS OBSERVED. VISUAL INSPECTION YIELDED NO UNUSUAL FINDINGS, DEFECTS OR ANOMALIES. THE REASON FOR THE RETURN AND FAILURE OF THE OIL MIST FILTER AND CATALYTIC CONVERTER COULD NOT BE CONFIRMED. THE MALE CONNECTOR WAS VISUALLY INSPECTED AND OBSERVED THAT THE PART WAS RECEIVED WITH A PIECE OF BROKEN TUBING JAMMED INSIDE AND COULD NOT BE REMOVED. THE REASON FOR THE RETURN OF THE MALE CONNECTOR WAS CONFIRMED. ASP COMPLAINT REF #: (B)(4).

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE OIL MIST FILTER, CATALYTIC CONVERTER, MALE CONNECTOR, AND VACUUM PUMP OIL WERE REPLACED TO RESOLVE THE MIST/HAZE ISSUE. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE. ASP COMPLAINT REF #: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A MIST OR HAZE EMITTING FROM THE STERRAD® 100 NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF AND LEAVE THE ROOM. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18599 STERRAD 100NX STERILIZER 1-DR STERRAD® EQUIPMENT MLR ADVANCED STERILIZATION PRODUCTS 10104 N/A 10705037014491

    Patients

    Seq Age Sex Outcome Treatment
    1