BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1883881 · Received October 27, 2010

    Report

    Report Number
    2150060-2010-00077
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: CIDEX OPA SOLUTION -(B)(4).(B)(4): HIGH BLOOD PRESSURE AND PULSE.

    Additional Manufacturer Narrative · 1

    (B)(6). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, THE HEALTH HAZARD EVALUATION AND SYSTEM HAZARD USE AND MISUSE ANALYSIS. THE DHR FOR THE AER WAS REVIEWED AND NO ISSUES WERE NOTED. THE SERVICE AND COMPLAINT HISTORY FOR THE ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER WAS REVIEWED FOR SIX MONTHS, SHOWS NO SIMILAR ISSUES WITH THE UNIT. TRENDING ANALYSIS FOR "HR-ALLERGIC SYMPTOMS" WAS COMPLETED FOR (B)(4) 2010 THROUGH (B)(4) 2010. THE TREND LINE LIES BELOW THE UPPER CONTROL LIMIT. THE HHES WERE REVIEWED AND THE RISK WAS FOUND TO BE NEGLIGIBLE. THE SHUMA WAS REVIEWED AND THE INITIAL RISK NUMBERS FOR USER REPEATED EXPOSURE HAZARDS WERE ALL 4 (SEVERITY OF 4, PROBABILITY OF 1) OR LOWER, WHICH WOULD BE EITHER CATEGORY I (BROADLY ACCEPTABLE RISK), OR CATEGORY II (AS LOW AS REASONABLY PRACTICABLE). THE EMPLOYEE WHO EXPERIENCED THE HUMAN REACTION WAS GIVEN A FOLLOW-UP PRESCRIPTION OF PREDNISONE. IT WAS REPORTED THAT AT THE TIME OF THE EVENT SHE CONTINUED TO HAVE PERIODIC EPISODES OF TACHYCARDIA. THEREFORE, SHE HAD A HOLTER MONITOR PLACED ON (B)(6) 2010, WHICH WAS FOLLOWED BY HER PRIMARY CARE PHYSICIAN. ACCORDING TO THE FACILITY CONTACT, THE HCW HAS RETURNED TO WORK, SHE IS NOT SCHEDULED TO WORK IN AREAS WITH CIDEX OPA. HER SYMPTOMS HAVE RESOLVED. AN ASP FIELD SERVICE ENGINEER (FSE) FOUND THAT THE UNIT WAS FUNCTIONING PROPERLY. THE FSE CHECKED THE UNIT FOR LEAKS BUT FOUND NONE. THE FSE RAN A TEST CYCLE AND FOUND THAT A HIGH-SURFACTANT DETERGENT, SELECT ENZYMATIC DETERGENT, WAS USED DURING THE WASH CYCLE. THE DETERGENT WAS FOUND TO BE FOAMING EXCESSIVELY AND THE FOAM WAS NOT RINSING COMPLETELY PRIOR TO OPA DISPENSE. THE FSE INFORMED THE CUSTOMER ABOUT THE DETERGENT FOAMING ISSUE AND RECOMMENDED ENZOL (NOTE: PER THE CUSTOMER ENZOL WAS LISTED AS A CHEMICAL USED IN THE ROOM). OTHER THAN THE FOAMING ISSUE THOUGH, THE UNIT WAS FOUND TO MEET ALL MANUFACTURING SPECIFICATIONS. DURING THE SERVICE, THE FACILITIES ENGINEER NOTED THAT THE EXHAUST FAN FOR THE ROOM WAS NOT FUNCTIONING AT THE TIME OF EXPOSURE; THE BREAKER FAN WAS TRIPPED. FOLLOW-UP AT A LATER DATE FOUND THAT THE UNIT WAS OPERATING PROPERLY. BUILDING MAINTENANCE SERVICED THE ROOM FOR AIR EXCHANGE SPECIFICATIONS AND THE ROOM MET PROPER ENVIRONMENTAL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CORRECTION: MISSING DATA ENTERED: ADVERSE EVENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NEW EMPLOYEE AT THE FACILITY HAD AN ALLERGIC REACTION TO CIDEX OPA SOLUTION UTILIZED IN THE ASP AUTOMATIC ENDOSCOPIC PREPROCESSOR (AER). SHE EXPERIENCED RAPID RESPIRATIONS, ITCHING OF THE ABDOMEN AND FACE, A FEVER OF 101 DEGREES, HIGH BLOOD PRESSURE OF 143/90 AND A HIGH PULSE OF 138. SHE SOUGHT MEDICAL TREATMENT AND WAS GIVEN A SHOT OF BENADRYL (50MG IV) IN THE EMERGENCY ROOM. SHE WAS FINE AFTER ONE DAY. THE FACILITY IS AWARE THAT THE AREA WHERE THE UNIT IS LOCATED DOES NOT MEET THE SPECIFICATIONS FOR THE NUMBER OF AIR EXCHANGES.

    Description of Event or Problem · 1

    IT WAS REPORTED POST IMPLANT A GASTRIC BAND PROCEDURE, THERE WAS A POSSIBLE LEAK IN THE BAND AS THE SURGEON TESTED THE BAND AND HE FOUND THE BAND COULD NOT BE USED NORMALLY. A NEW BAND WAS REPLACED. THE SURGEON THOUGHT THE LEAK IN THE BAND SEEMED LIKE A CUT THROUGH BY SUTURE (ETHIBOND). THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER AER EQUIPMENT KOG MINNTECH CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR BENEDRYL AND PREDNISONE