BEUDAMED
    FDA Adverse Event Summary report: N

    RAPID-FILL AUTOMATED SYRINGE FILLING SYSTEM

    MDR report key: 1381030 · Received April 28, 2009

    Report

    Report Number
    1381030
    Date Received
    April 28, 2009
    Date of Event
    April 19, 2009
    Report Date
    April 23, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE SPINAL BLOCK WAS PLACED FOR THE SCHEDULED CESAREAN SECTION, THE PATIENT WAS INADVERTENTLY ADMINISTERED SUCCINYLCHOLINE INSTEAD OF EPHEDRINE. THE PATIENT BECAME PARALYZED AND HAD AWARENESS OF DIFFICULTY BREATHING FOR ABOUT 60 SECONDS. THE PATIENT REQUIRED A BRIEF PERIOD OF INTUBATION AND VENTILATORY SUPPORT. THE PATIENT RECOVERED SATISFACTORILY FROM ANESTHESIA. ADDITIONAL INFORMATION OBTAINED FROM THE SITE: AFTER THIS OCCURRENCE, PHARMACY IMPLEMENTED A NEW PROCESS WHEREBY THEY MANUALLY AFFIX A YELLOW WARNING STICKER THAT STATES "WARNING: PARALYZING AGENT" TO THE BACKSIDE (WHITE) OF THE LABEL FOR THE SUCCINYLCHOLINE. RIGHT NOW, ONE OF OUR PHARMACISTS IS RESEARCHING SWITCHING TO A DIFFERENT MANUFACTURER TO PURCHASE THESE DRUGS FROM. THE PRODUCT BEING RESEARCHED COMES IN PRE-FILLED SYRINGES AND IS CLEARLY LABELED FROM ALL SIDES/ANGLES (WITHOUT OBLITERATING THE GRADIANT MARKINGS). THIS PRODUCT FEATURES BETTER LABELING. INVESTIGATION: THE RAPID-FILL AUTOMATED SYRINGE FILLING SYSTEM (ASF) AUTOMATES ON-LINE LABEL PRINTING BY PRINTING THE LABEL INFORMATION AND CUTTING THE FINISHED, LABELED SYRINGE FROM THE STRIP. THE LABEL IS AFFIXED TO ONE-HALF OF THE SYRINGE BARREL SO THAT GRADATIONS ON THE SYRINGE BARREL ARE LEGIBLE AND IT DOES NOT IMPAIR THE ABILITY TO CHECK THE MEDICATION DOSAGE. THE ASF IS USED TO FILL AND LABEL SYRINGES OF EPHEDRINE (VIOLET-COLORED LABEL) AND SUCCINYLCHOLINE (FLUORESCENT RED-COLORED LABEL). THE LABELED SYRINGES OF EPHEDRINE AND SUCCINYLCHOLINE ARE STORED IN THE SAME DRAWER OF THE PYXIS UNIT. A STAFF MEMBER REMOVED THE SYRINGE LABELED "SUCCINYLCHOLINE" FROM THE PYXIS AND ADMINISTERED IT INSTEAD OF THE ORDERED DOSE OF EPHEDRINE. WHEN THE SYRINGE IS IN THE POSITION TO ALLOW VISUALIZATION OF THE GRADATION MARKINGS ON THE SYRINGE BARREL, ONLY THE WHITE-COLORED BACKSIDE OF THE LABEL IS VISIBLE. APPARENTLY, THE STAFF MEMBER DID NOT CHECK THE PRINTED MEDICATION LABEL PRIOR TO ADMINISTRATION. A ROOT CAUSE ANALYSIS OF THIS OCCURRENCE WILL BE COMPLETED. AN INTERIM MEASURE HAS BEEN IMPLEMENTED. A YELLOW-COLORED STICKER THAT STATES "WARNING: PARALYZING AGENT" IS AFFIXED TO THE WHITE BACKSIDES OF THE SUCCINYLCHOLINE LABELS BEFORE THEY ARE STORED IN THE PYXIS. THERE HAVE BEEN NO OTHER COMPLAINTS WITH THIS DEVICE OTHER THAN THERE WERE SOME ISSUES WITH A BATCH OF SYRINGES WHERE THE LABEL WENT OVER THE MARKINGS ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID-FILL AUTOMATED SYRINGE FILLING SYSTEM AUTOMATED SYRINGE FILLING SYSTEM LHI BAXA CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR