BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS HIGH FLOW INSUFFLATION UNIT

    MDR report key: 2832121 · Received November 3, 2012

    Report

    Report Number
    8010047-2012-00409
    Event Type
    Other
    Date Received
    November 3, 2012
    Date of Event
    June 29, 2012
    Report Date
    October 3, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCX
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO WITHOUT SUCCESS. PER THE INFO SUBMITTED BY THE USER FACILITY IN THE 3500A FORM, ¿THERE HAS BEEN NO FURTHER CONTACT MADE TO THE HOSPITAL BY THE PT TO-DATE IN REGARDS TO THE POSSIBLE BLOOD EXPOSURE CONCERNS. BIOMEDICAL ENGINEERING INSPECTED THE INSUFFLATOR AND REPLACED THE INTERNAL TUBING. THE BIOMED TECHNICIAN REPORTED THAT THERE WAS FLUID WITH NO VISIBLE BLOOD FOUND IN THE INTERNAL TUBING. THE BIOMED TECH REPORTED THAT THERE WAS FLUID WITH NO VISIBLE BLOOD FOUND IN THE INTERNAL TUBING. TESTING OF THE FLUID IN THE LAB DID REVEAL THE PRESENCE OF BLOOD. BUT IT TOO, WAS NOT ENOUGH TO TYPE. IT WAS NOTED THAT TUBING MADE BY A DIFFERENT MANUFACTURE STANDARD SUCTION TUBING WAS BEING USED AND THAT THE MFR INDICATES THAT THIS MAY IMPAIR PERFORMANCE AND LEAD TO INCORRECT OPERATION. ACTION TAKEN: A ROOT CAUSE ANALYSIS WAS COMPLETED. CORRECTIVE ACTIONS TAKEN INCLUDE THE PURCHASE OF CORRECT TUBING WITH FILTER AND A WRITTEN PROCESS FOR MAINTAINING AND OPERATING THE INSUFFLATOR.¿ THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, USE OF A NON-OLYMPUS SUCTION TUBING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: ¿DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AS PART OF THE SURGERY PREPARATION, THE SUCTION TUBE WAS CONNECTED TO THE INSUFFLATOR BY THE CIRCULATING NURSE. THE PROCEDURE WAS STARTED. THE DOCTOR REQUESTED THAT THE INSUFFLATOR BE STARTED. SHORTLY AFTER THE START OF THE INSUFFLATOR, THE SURGEON NOTED SERIOUS FLUID (SOME CLEAR YELLOWISH FLUID) WAS STUCK IN THE SUCTION TUBE. THE TUBING WAS IMMEDIATELY DISCONNECTED AND REMOVED FROM THE FIELD. A SMALL AMOUNT OF BLOODY FLUID FLOWED OUT OF THE INSUFFLATOR. NEW TUBING AND A NEW INSUFFLATOR MACHINE WERE BROUGHT INTO THE ROOM. THE PROCEDURE CONTINUED. THE DOCTOR INDICATED THAT IT DID NOT APPEAR THAT ANY SIGNIFICANT AMOUNT OF FLUID WENT THROUGH THE TUBING INTO THE PT (POSSIBLY AEROSOLIZING INTO THE PT¿S ABDOMEN). IT COULD NOT BE DETERMINED IF OLD BLOOD/ FLUID IN THE TUBE WAS THE PT¿S OR NOT. (THE LABORATORY WAS ABLE TO DETERMINE THAT THERE WAS BLOOD IN THE FLUID BUT THERE WAS NOT ENOUGH TO TYPE THE BLOOD). THE PT WAS TREATED POST-OPERATIVELY AS A POSSIBLE BLOOD EXPOSURE WITH PATIENT NOTIFICATION/DISCUSSION WITH AN INFECTIOUS DISEASE DOCTOR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FLOW INSUFFLATION UNIT INSUFFLATION UNIT FCX OLYMPUS MEDICAL SYSTEMS CORPORATION UHI-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other