BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIFILL IV ROBOT

    MDR report key: 2102320 · Received May 19, 2011

    Report

    Report Number
    MW5020691
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    January 5, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXA CORP
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ROUTINE QUALITY CONTROL TESTING OF THE INTELLIFILL IV ROBOT BY BAXA REVEALED CONTAMINATION WHEN USING THE VIAL MODE. TESTING IS A TWO DAY PROCESS EACH WEEK AND INVOLVES PREPARING SYRINGES OF A GROWTH MEDIUM (TRYPTIC SOY BROTH; TSB) ON THE DEVICE (IN THE SAME MANNER THAT MEDICATIONS ARE PREPARED) AND A SERIES OF SWABS AND AIR SAMPLES WITHIN THE DEVICE. THE DEVICE PREPARES SYRINGES IN TWO DIFFERENT METHODS CALLED RESERVOIR AND VIAL MODE. THESE SYRINGES AND SAMPLES ARE THEN INCUBATED TO DETECT THE PRESENCE OF BACTERIA. DURING THE PERIOD FROM (B)(6) 2008 UNTIL (B)(6) 2010, THERE WERE RARE REPORTS OF "POSITIVE" OR CONTAMINATED SAMPLES. ESSENTIALLY THE DEVICE WAS CONSIDERED TO BE "IN CONTROL". DURING THE MONTH OF (B)(6) 2011, MULTIPLE POSITIVE SAMPLES WERE IDENTIFIED; ALL PREPARED IN VIAL MODE. IDENTIFYING THAT VIAL MODE PREPARATION WAS USED IS SIGNIFICANT DUE TO THE METHOD THE DEVICE USES TO DISINFECT THE VIAL. ISOLATES FORM THESE POSITIVE SAMPLES WERE IDENTIFIED AS (B)(6). THE FIELD SERVICE REPRESENTATIVE FOR INTELLIFILL WAS CONTACTED AND BROUGHT ON SITE TO ASSIST WITH THIS PROBLEM ON (B)(6) 2011. HE IDENTIFIED THAT THE DEVICE WAS NOT PROPERLY DISINFECTING THE SEPTUM OF THE TSB VIALS. HE ADJUSTED THE DEVICE SETTINGS AND EDUCATED STAFF REGARDING THE PROPER HEIGHT FOR THE ALCOHOL WICK THAT DISINFECTS THE SEPTUM. HOWEVER, REPEAT TESTING OF VIAL MODE AFTER THESE ADJUSTMENTS YIELDED 3 OUT OF 10 POSITIVE SYRINGES. THESE SYRINGES WERE DETECTED ON (B)(6) 2011. TESTING PERFORMED ON (B)(6) 2011 RESULTED IN 2 OUT OF 10 AND 10 OUT OF 10 POSITIVE SYRINGES, RESPECTIVELY. ON (B)(6) 2011, INFECTION CONTROL WAS CONTACTED FOR ASSISTANCE WITH THIS SITUATION. IN ADDITION, BAXA WAS NOTIFIED AGAIN OF THE CONTINUED CONTAMINATION. MEDICATIONS PREPARED BY THE ROBOT IN VIAL MODE WERE QUARANTINED. NO MEDICATIONS ARE CURRENTLY BEING PREPARED ON THE ROBOT USING VIAL MODE. DNA "TYPING" FORM POSITIVE SAMPLES HAS BEEN COMPLETED. THE DEVICE MAY BE PRONE TO CONTAMINATION WHEN RUN IN VIAL MODE. AS SUCH, THE DEVICE IS CURRENTLY NOT BEING RUN IN VIAL MODE. IN (B)(6), THE DEVICE WAS RE-CERTIFIED BY BAXA. BAXA EXECUTIVES VISITED TO EVALUATE THE DEVICE AND DISCUSS THE ACTION PLAN IN (B)(6). FURTHER EVALUATION OF THE DEVICE WILL BE COMPLETED IN COLLABORATION WITH THE (B)(6) INSTITUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIFILL IV ROBOT IV ROBOT NEP BAXA CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability