BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 1671554 · Received May 3, 2010

    Report

    Report Number
    1823260-2010-02603
    Event Type
    Malfunction
    Date Received
    May 3, 2010
    Date of Event
    March 16, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE INSTRUMENT DID NOT EXHIBIT ANY INSTRUMENT OR PO2 ELECTRODE ISSUES. THE INSTRUMENT WAS WORKING WITHIN SPECIFICATIONS. TECHNICAL SUPPORT RELATED THE REPORTED PROBLEM TO A HANDLING ISSUE RATHER THAN TO AN INSTRUMENT ISSUE. THE BAROMETRIC PRESSURE SETTING ON THE INSTRUMENT WAS ALSO ADJUSTED, FURTHER IMPROVING THE SITUATION. THE CUSTOMER REPORTED THAT THERE HAVE BEEN NO ERRONEOUS PATIENT RESULTS GENERATED ON THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED 5 QUESTIONABLE PO2 RESULTS ON A CAP CRIT CARE/AQUEOUS BLOOD GAS SURVEY. ONE PO2 RESULT FROM THE ROCHE OMNI WAS DETERMINED TO BE DISCREPANT. PO2 = 151 MMHG CAP ACCEPTABLE RANGE = 102 - 136 MMHG AS THESE RESULTS WERE FOR CAP SURVEY SAMPLES, NO PATIENTS WERE AFFECTED. APPROXIMATELY 1 MONTH AFTER ANALYZING THE SURVEY SPECIMENS THE CUSTOMER REPORTED QUALITY CONTROLS RUNNING HIGH, OUT-OF-RANGE, FOR PO2. THE CUSTOMER WAS INSTRUCTED BY THE TECHNICAL SERVICES SUPPORT REPRESENTATIVE TO INSTALL A NEW PO2 ELECTRODE AS THE OLD ELECTRODE HAD BEEN IN SERVICE SINCE (B) (6) 2008. THE CUSTOMER STATED THAT QUALITY CONTROLS WERE "OK" AFTER INSTALLING THE NEW ELECTRODE. AT THE SAME TIME THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A POOR FLUIDICS CONNECTION AT THE DOCKING MECHANISM. THE DOCKING MECHANISM WAS CLEANED AND BOTTLES WERE RESEATED. ELECTRODES WERE ALSO RESEATED AND FLUIDICS DIAGNOSTICS WERE PERFORMED. THE CUSTOMER PERFORMED QUALITY CONTROL AND ANALYZED SAMPLES WITHOUT ALARMS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE DEVICE WAS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THIS IS CASE 12 OF 22 REPORTED TO BAXTER (B)(4) BY THE SENIOR NURSE OF A PERITONEAL DIALYSIS (PD) CENTER. IT WAS REPORTED THAT WHEN OPENING THE TRANSFER SET, THE TWIST CLAMP CRACKED/BROKE. AS A CONSEQUENCE THE SET STARTED LEAKING. THE PD THERAPY WAS STOPPED. THE PATIENT HAD BEEN ON CONTINOUS AMBULATORY PD THERAPY FOR AT LEAST 5 YEARS. REPORTEDLY, THE CUSTOMER WAS CAREFUL WHEN OPENING/CLOSING THE TRANSFER SET. ALCOHOL-ETHANOL 70% BASED DISINFECTANTS WERE USED FOR STERILIZATION OF THE SKIN AND CATHETER, TITANIUM ADAPTER AND TRANSFER SET (NOT SPRAY, BUT COTTON WOOL). THESE DISINFECTANTS MUST BE USED BECAUSE THE AREA IS DESERT AND IT IS VERY WINDY AND DUSTY. THESE METHODS OF STERILIZATION HAD BEEN USED FOR A FEW YEARS AND THERE WEREN'T PROBLEMS LIKE THIS BEFORE. ACCORDING TO THE CUSTOMER, THE PROBLEMS WITH THE TRANSFER SET STARTED IN (B)(6) 2010. THE EXACT OCCURRENCE DATE OF THIS PARTICULAR EVENT IS UNKNOWN. NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO CLINICAL CONSEQUENCES FOR THE PATIENT INVOLVED HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI BLOOD GAS ANALYZER JJC ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1