BEUDAMED
    FDA Adverse Event Summary report: N

    V-PRO STERILIZER

    MDR report key: 2252019 · Received September 16, 2011

    Report

    Report Number
    3005899764-2011-00019
    Date Received
    September 16, 2011
    Date of Event
    November 3, 2010
    Report Date
    September 16, 2011
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    MLR
    PMA / PMN Number
    K062297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THE UNIT BEGAN TO EMIT A SMOKE AND SMELL DURING A PROCESSING CYCLE. HOSPITAL PERSONNEL DID NOT KNOW HOW TO UNPLUG UNIT, HOWEVER USER FACILITY BIOMEDICAL PERSONNEL RESPONDED AND UNPLUGGED THE STERILIZER. NO INJURIES TO PATIENTS OR HOSPITAL STAFF WERE REPORTED. A STERIS TECHNICIAN INSPECTED THE UNIT AND FOUND THE VACUUM PUMP WAS NOT OPERATING PROPERLY. THE TECHNICIAN REPLACED THE PUMP AND CATALYTIC CONVERTER, RAN A LEAK TEST AND PLACED UNIT BACK INTO SERVICE. THE CAUSE OF THIS EVENT APPEARS TO BE PREMATURE WEAR OF THE VACUUM PUMP AND FILTERING COMPONENTS. THE PREMATURE WEAR OF THE VACUUM PUMP/FILTERING COMPONENTS IS DUE TO AGING. THE BREAKDOWN LEAVES VOIDS WITHIN THE FILTER, ALLOWING OIL MIST TO PASS THROUGH WITHOUT BEING FILTERED. THE VACUUM PUMP OIL IS NON-TOXIC AND NOT CONSIDERED HAZARDOUS; THE AMOUNT EMITTED AND THE FREQUENCY AT WHICH IT OCCURS IS LIMITED. IN SENSITIVE INDIVIDUALS SHORT TERM NUISANCE EFFECTS MAY OCCUR (I.E. HEADACHE) WITH NO EXPECTED LONG TERM EFFECTS. THIS ISSUE IS THE OBJECT OF A VOLUNTARY FIELD CORRECTION INITIATED BY STERIS CORPORATION ON (B)(4) 2011 (RECALL # Z-3041-2011) OF AMSCO V-PRO 1 AND V-PRO 1 PLUS STERILIZERS. AS PART OF THE VOLUNTARY FIELD CORRECTION, STERIS DEVELOPED A SERIES OF QUALITY IMPROVEMENTS TO THE OIL MANAGEMENT AND ASSOCIATED SOFTWARE TO ENHANCE THE RELIABILITY AND OPERATION OF THE V-PRO SYSTEM, WHICH WILL BE INSTALLED ON AFFECTED UNITS. THESE ISSUES DO NOT AFFECT THE STERILIZATION OF INSTRUMENTS PROCESSED IN THE STERILIZER. THE DEVICE HISTORY RECORD EVIDENCES THE UNIT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE UNIT IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY USER FACILITY BIOMEDICAL PERSONNEL. STERIS HAS SCHEDULED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE STERILIZER FOR (B)(6) 2011.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-PRO STERILIZER STERILIZER MLR STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other