BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1274896 · Received December 23, 2008

    Report

    Report Number
    2084725-2008-00847
    Event Type
    Injury
    Date Received
    December 23, 2008
    Date of Event
    November 28, 2008
    Report Date
    December 4, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE: HUMAN REACTION. CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FIELD ENGINEER CONFIRMED THE MACHINE WORKED PROPERLY.

    Additional Manufacturer Narrative · 1

    DEVICE SERIAL NUMBER: PER THE AFFILIATE, THE STERRAD NX, (B)(4), USED DURING SURGERY WAS A TEMPORARY UNIT INSTALLED IN THE HOSPITAL FOR DEMONSTRATION. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER. A REVIEW OF THE DHR (DEVICE HISTORY REVIEW) FOR THE STERRAD NX SHOWED THE SYSTEM MET ALL THE MANUFACTURER'S SPECIFICATIONS AT THE TIME OF RELEASE FOR SHIPMENT AND THERE WERE NO ISSUES RELATED TO THE FAILURE MODE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD NX WAS REVIEWED. NO TREND FOR HR-OTHER FAILURES FOR SIX MONTHS PRIOR TO THE EVENT WAS NOTED. THERE WERE 15 COMPLAINTS OF HR-OTHER THAT HAD OCCURRED DURING THE YEAR ACROSS THE STERRAD NX PRODUCT LINE FROM SEPTEMBER 2009 THROUGH AUGUST 2010. THE NUMBER OF COMPLAINTS DOES NOT CONSTITUTE A SIGNIFICANT TREND. THE FSE ASSESSED THE STERRAD UNIT AND CONFIRMED THAT THE UNIT WORKED PROPERLY. NO PARTS WERE REQUIRED TO BE RETURNED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE RESULTS OF THE ANALYSIS DEMONSTRATED THERE WAS NO CONNECTION BETWEEN THE SURGICAL COMPLICATION AS DESCRIBED AND THE STERRAD NX UNIT. NO FURTHER ACTION IS REQUIRED. ASP WILL MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER ALLEGED THAT AFTER USING AN ARTHROSCOPE THAT WAS STERILIZED IN THE STERRAD NX, THE PT EXPERIENCED "OOZING AND FROTHY SECRETION" FROM HER CLOSED WOUND SITE ON HER LEFT KNEE AFTER SURGERY. THE WOUND SITE WAS OPENED UP AND TREATED WITH AIR TO DRY THE SITE. THE PT IS STILL EXPERIENCING THE SYMPTOM AND SHE IS HOSPITALIZED AGAIN. BLOOD TEST AND TEMPERATURE CHECK WAS PERFORMED AND NO PROBLEM WAS FOUND. DOCTOR STATED THAT THE OOZING WAS NOT DUE TO BACTERIA BECAUSE THE WOUND SITE DID NOT STINK OF FOUL SMELL AND THE PT DID NOT EXPERIENCE BURNING SENSATION OR PAIN ON THE SITE. PER AFFILIATE, THE DOCTOR THOUGHT THAT THE ARTHROSCOPE WAS NOT NECESSARILY STERILIZED IMPROPERLY. IT WAS REPORTED THAT THE ARTHROSCOPE WAS FROM A COMPLETED CYCLE AND THE COLOR OF THE CHEMICAL INDICATOR CHANGED PROPERLY. THE FIELD ENGINEER ASSESSED THE UNIT.

    Description of Event or Problem · 1

    VALVED PORT WAS REMOVED FROM PT DUE TO LEAKAGE OF THE CATHETER TUBING. THE PORT WAS REPLACED WITH NO COMPLICATIONS RESULTING TO THE PT. THE USED DEVICE IS BEING RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR