BEUDAMED
    FDA Adverse Event Other Summary report: N

    RATE FLOW REGULATOR IV SET

    MDR report key: 1193234 · Received October 6, 2008

    Report

    Report Number
    2523676-2008-00083
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 24, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K952810
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES INVOLVED IN THE REPORTED INCIDENTS WERE NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED AND THE REPRESENTATIVE SAMPLES INDICATED TO BE SENT FOR EVALUATION, HAVE NOT YET BEEN RECEIVED. ALL AVAILABLE INFORMATION WAS SENT TO THE MANUFACTURER LEVENTON, (B) (4) FOR INVESTIGATION. REPRESENTATION SAMPLES KEPT AT LEVENTON, (B) (4) WERE ANALYZED AND SUBJECTED TO A FLOW RATE STABILITY TEST. NONE OF THE EVALUATED UNITS HAVE SHOWN FLOW RATES OUT OF SPECIFICATION. THE BATCH RECORD FOR THE AFFECTED LOT NUMBER HAS BEEN REVIEWED AND NO INCIDENCE WAS DETECTED IN THE CONTROLS DONE DURING THE MANUFACTURING PROCESS OR IN THE CONTROL DONE BEFORE THE RELEASE OF THIS PRODUCT. IN CONCLUSION, LEVENTON HAS CONSIDERED THAT THE OVER INFUSION PROBLEM DETECTED BY THE CUSTOMER IS POSSIBLY DUE TO A LACK OF THE PREVIOUS ADJUSTMENT OF THE FLOW RATE RECOMMENDED IN THE INSTRUCTIONS FOR USE SUPPLIED WITH THE PRODUCT, BECAUSE THE SCALE PRINTED IN THE DIAL IS AN APPROXIMATION. WITHOUT THE ACTUAL SAMPLES, A MORE ACCURATE EVALUATION OF THE POSSIBLE CAUSE COULD NOT BE DETERMINED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. IT IS TO BE NOTED THAT THE INSTRUCTIONS FOR USE INDICATE: AFTER VENIPUNCTURE HAS BEEN PERFORMED, CONNECT RATE FLOW REGULATOR PEDIATRIC I.V SET MALE DISTAL END TO THE VENIPUNCTURE DEVICE. TURN THE DIAL TO THE DESIRED FLOW RATE POSITION. THE RATE FLOW REGULATOR DIAL INDICATES FLOW RATE IN ML/HOUR. DESIRED RATE FLOW MAY BE CALCULATED BY DIVIDING DESIRED INFUSION VOLUME BY DESIRED INFUSION TIME. COUNT THE NUMBER OF DROPS WHICH FALL IN THE DRIP CHAMBER DURING ONE MINUTE OR, AT LOW FLOW RATES, MEASURE THE TIME BETWEEN TWO DROPS. CONVERT DROPS/MINUTE TO FLOW RATE IN ML/HOUR. IF FLOW RATE CALCULATED IN STEP 7 DOES NOT CORRESPOND TO THE FLOW RATE DESIRED, TURN DIAL SLIGHTLY IN THE APPROPRIATE DIRECTION AND REPEAT STEPS 6 AND 7 UNTIL THE DESIRED FLOW RATE IS OBTAINED. PRECAUTION: THE RATE FLOW REGULATOR SHOULD NOT BE LEFT IN OR NEAR THE OPEN POSITION WHEN ADMINISTERING FLUID TO A PATIENT AS THE FLOW RATE CAN RAPIDLY INCREASE FROM 250ML/H TO ADMINISTERING 2500 ML/H. AT THIS RATE, A LITER BOTTLE WOULD BE EMPTIED IN LESS THAN 25 MINUTES. THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE AGAINST THIS PRODUCT OR LOT. IF ADDITIONAL REPRESENTATIVE SAMPLES ARE RECEIVED FROM THE FACILITY, THEY WILL BE FORWARDED TO LEVENTON FOR EVALUATION. IF ANY PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: TWO PATIENTS RECEIVING INFUSIONS OF TYSABRI BOTH DEVELOPED CHEST PAIN DURING THE INFUSION, NURSE CHECKED RATE FLOW DIAL AND DISCOVERED THAT THE 250ML/H MARKING WAS RIGHT NEXT TO THE OPEN POSITION-THERE WAS NO SPACE BETWEEN THE 2 MARKINGS. THE INFUSIONS WERE STOPPED AND THEIR CHEST PAIN SUBSIDED. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED NEITHER PATIENT SUFFERED ANY ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENTS. THE ACTUAL SAMPLES WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. THE FACILITY WILL BE SENDING UNUSED SAMPLES OF THE REPORTED LOT FROM THEIR INVENTORY FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RATE FLOW REGULATOR IV SET REGULATOR IV SET FPA B. BRAUN MEDICAL, INC. NA 081048L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other