BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 3073217 · Received April 23, 2013

    Report

    Report Number
    2084725-2013-00191
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: 07/24/2000. LIST CORRECTION/REMOVAL REPORTING NUMBER: CORRECTED REPORTING NUMBER FROM Z-1026-1027-2013 TO Z-0744-0746-2014. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, AND SYSTEM HAZARD AND USER MISUSE ANALYSIS. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND INDICATED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCED "ODOR/SMELLS" ISSUE. THE UNIT MET SPECIFICATION AT THE TIME OF ITS RELEASE. THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST 6 MONTHS ((B)(6) 2012 ¿ (B)(6) 2013) DID NOT REVEAL A SIGNIFICANT TREND. THE COMPLAINT TRENDING FOR PROBLEM CODE ¿ODOR/SMELLS¿ IDENTIFIED A SIGNIFICANT TREND OVER THE PAST 12 MONTHS ((B)(6) 2012 ¿ (B)(6) 2013). THIS RISK IS CONSIDERED AS LOW AS REASONABLY PRACTICAL. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) DEFINES THE RISK AS LOW AS REASONABLY PRACTICAL FOR EXPOSURE TO ODOR OR ODORANTS. THE FSE CHANGED THE OIL AND THE UNIT WAS LEFT IN WORKING ORDER. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. REVIEW OF THE TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND. AS A RESULT, ROOT CAUSE OR ASSIGNABLE CAUSE ANALYSIS COULD NOT BE PERFORMED. NO FURTHER ACTION IS REQUIRED; HOWEVER, THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    IF REMEDIAL ACTION INITIATED, CHECK TYPE: CORRECTED REMEDIAL ACTION TYPE FROM RECALL TO NOTIFICATION. LIST CORRECTION/REMOVAL REPORTING NUMBER: CORRECTED REPORTING NUMBER FROM FA-092 TO Z-1026-1027-2013.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED AN EVENT OF A "SMELL" (ODOR) EMITTING FROM THE STERRAD 100S STERILIZER "AT THE START OF CYCLE." THERE WAS NO REPORT OF HUMAN REACTION. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE PTA BALLOON CATHETER DETACHED IN A LEFT UPPER ARM FISTULA AFTER BEING INFLATED WITHIN A STENT. THE DETACHED TIP REMAINED ON THE GUIDE WIRE AND WAS SUCCESSFULLY RETRIEVED WITHOUT INCIDENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173734 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0101005904

    Patients

    Seq Age Sex Outcome Treatment
    1