BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTAMIX 2400 COMPOUNDER

    MDR report key: 2163675 · Received June 13, 2011

    Report

    Report Number
    1419106-2011-00008
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE EVENTS OR PT INJURY WERE REPORTED FROM THE INFUSION OF THIS TPN. REVIEW OF DATABASE BLACK BOX FILES WAS PERFORMED. THE DEVICE OPERATED AS INTENDED AND DELIVERED THE CORRECT ORDER AMOUNT OF THE REQUESTED INGREDIENT. BAXA TECHNICAL SUPPORT REITERATED, TO THE CUSTOMER, THE CORRECT USAGE OF THE EM2400 COMPOUNDER AS STATED IN THE OPERATORS MANUAL. HOW TO PROPERLY SET UP THE COMPOUNDER, SPECIFICALLY, "T.A.S.H.L." AN ACRONYM USED TO ASSIST USERS DURING THE "PRIME AND VERIFY" PROCESS. A REVIEW OF RISK DOCUMENTATION WAS PERFORMED, AND IT HAS BEEN CONCLUDED THAT THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED. BAXA REQUESTED ALL OF THE INFO NEEDED TO BE ABLE TO INVESTIGATE THE REPORTED ISSUE. BAXA WAS PROVIDED WITH THE EM2400 DATABASE AND THE BLACK BOX FILES. BASED ON THE PROVIDED INFO, THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE USER ERROR IN THE SETUP OF THE EM2400 COMPOUNDER (THE USER DID NOT FOLLOW THE RECOMMENDED PROCESS DURING THE PRIME AND VERIFY STEP DURING SET-UP OF THE COMPOUNDER). THE INLET (TUBING CONNECTING THE INGREDIENT TO THE VALVE SET) OF THE MGSO4 INGREDIENT WAS INCORRECTLY ATTACHED TO PORT 19 (CONNECTION POINT ON THE VALVE SET). THE BLACK BOX DATA FOR THE EM2400 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUMES OF THE REQUESTED INGREDIENTS IN THE CORRECT ORDER. HOWEVER, THE REVIEW ALSO SHOWS THAT THE USER IGNORED THE BUBBLE ALARM NOTIFICATIONS. THESE MESSAGES WERE GENERATED BECAUSE NO INGREDIENT WAS COMING THROUGH THE EMPTY PORT 21. DUE TO THE SHORT AMOUNT OF TIME BETWEEN THE BUBBLE ALARM NOTIFICATION AND WHEN COMPOUNDING RESUMED IT DOES NOT APPEAR THAT PROPER INVESTIGATION INTO A POSSIBLE CAUSE FOR THE BUBBLE(S) WAS CONDUCTED BY THE PHARMACY TECHNICIAN DURING THE COMPOUNDING PROCESS. BAXA CLINICAL PHARMACY SPECIALIST ISSUED A DUTY TO WARN LETTER TO THE DIRECTOR OF PHARMACY AT THE FACILITY REGARDING THE MISUSE OF THE EM2400 COMPOUNDER. EM2400 COMPOUNDER BLACK BOX DATA: THIS IS A LOG OF THE COMMANDS THE COMPOUNDER RECEIVES AND THE ACTIONS THE COMPOUNDER TAKES TO PRODUCE THE TPN BAG. EM2400 BARCODE SCANNER LABEL: LABELS PROVIDED TO THE CUSTOMER IN ORDER TO CORRECTLY IDENTIFY WHICH INGREDIENT IS CONNECTED TO A SPECIFIC PORT. THE LABEL IS TO BE PLACED ON EVERY INGREDIENT HUNG ON THE COMPOUNDER FOR BARCODE IDENTIFICATION. THIS IS FIRST CONFIRMED DURING THE 'PRIME AND VERIFY' STAGE DURING DAILY SET UP. A SECONDARY REVIEW OF THE COMPOUNDER SET UP IS RECOMMENDED IN THE OPERATORS MANUAL AND IS REITERATED DURING INSTALLATION TRAINING PROVIDED BY BAXA. PRIME AND VERIFY: THE PROCESS OF SETTING UP THE COMPOUNDER; SCANNING THE LABELS FOR EACH PRODUCT, THEN THE PUMP WILL PULL A SMALL AMOUNT OF INGREDIENT FROM EACH PRODUCT CONNECTED TO THE COMPOUNDER. DURING THIS PROCESS THE USER IS INSTRUCTED TO PHYSICALLY AND VISUALLY VERIFY THE CORRECT INGREDIENT IS PUMPING, BY HOLDING THE TUBING AND FOLLOW THE INGREDIENT MOVEMENT TO THE PORT. BUBBLE/OCCLUSION ALARM: SENSOR USED TO DETECT BUBBLES/OCCLUSIONS WITHIN THE TUBING WHILE THE COMPOUNDER IS PUMPING. THESE ALARMS ARE TURNED OFF DURING 'PRIME AND VERIFY' BECAUSE THE COMPOUNDER IS CLEARING THE FLUID PATHWAY OF ALL BUBBLES AND OCCLUSIONS. ONCE 'PRIME AND VERIFY' HAS BEEN COMPLETED THESE ALARMS ARE AUTOMATICALLY TURNED BACK ON. T.A.S.H.L.: (TOUCH, ATTACH, SPIKE, HANG, LABEL) THE USER IS INSTRUCTED TO MAINTAIN PHYSICAL CONTACT WITH THE INGREDIENT AND TUBING DURING THIS PROCESS. TOUCH THE CAP ON THE INGREDIENT SPECIFIC PORT. ATTACH THE REQUIRED TUBE TO THE PORT. SPIKE THE INGREDIENT CONTAINER USING THE SAME TUBE. HANG THE INGREDIENT ONTO THE VIAL RACK ATTACHED TO THE COMPOUNDER. LABEL THE INGREDIENT USING THE EM2400 BARCODE SCANNER LABELS TO IDENTIFY THE CORRECT PORT.

    Description of Event or Problem · 1

    ON (B)(6), IT WAS REPORTED TO BAXA TECHNICAL SUPPORT THAT A CONTAINER OF MGSO4 WAS ACCIDENTALLY HUNG ON PORT 19 INSTEAD OF PORT 21 ON THE VALVE SET OF THE EM2400 COMPOUNDER. THE RESPONSIBLE PHARMACY TECHNICIAN CONNECTED THE CONTAINER OF MGSO4 TO THE INCORRECT PORT AND DID NOT PHYSICALLY OR VISUALLY CONFIRM THE PORT CONNECTION DURING 'PRIME AND VERIFY.' THE INCORRECT TPN BAGS WERE COMPOUNDED AND DELIVERED TO PTS ON (B)(6). THE ISSUE WAS DISCOVERED ON (B)(6). THE PHARMACIST RECEIVED A MESSAGE STATING THAT THE INGREDIENT ON PORT 21 WAS EMPTY. THE PHARMACIST CHECKED THE INGREDIENT AND FOUND THAT THE CONTAINER WAS FULL. THE MESSAGE WAS BYPASSED AND COMPOUNDING WAS CONTINUED. DURING THE PUMPING PROCESS THE PHARMACIST SAW NO INGREDIENT WAS BEING DRAWN FROM THE CONTAINER. THE PHARMACIST THEN PHYSICALLY HELD THE CONTAINER, TRACED THE TUBING AND FOUND THAT IT WAS INCORRECTLY CONNECTED TO PORT 19. PORT 21 WAS FOUND TO BE UNUSED AS IT WAS STILL CAPPED. THREE PTS RECEIVED TPN BAGS THAT DID NOT CONTAIN THE ORDERED MGSO4. NO ADVERSE EVENTS OR PT INJURY RESULTED FROM THE INFUSION OF THIS TPN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX 2400 COMPOUNDER EM2400 LHI BAXA CORP. 2400-M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention