BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 600 UNIVERSAL PUMP

    MDR report key: 1013311 · Received March 14, 2008

    Report

    Report Number
    1419106-2008-00002
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S SUBSEQUENT INVESTIGATION REVEALED THAT DURING SET UP OF THE COMPOUNDER, THE CUSTOMER INADVERTENTLY PLACED THE INLET (TUBING) FROM THE INGREDIENT KCL TO THE INGREDIENT PORT (ATTACHMENT AT COMPOUNDER SITE) NACL THEREBY CREATING SALINE BAGS WITH KCL INSTEAD OF NACL. CUSTOMER REPORTED TO BAXA THAT THEY DID NOT FOLLOW THE VERIFY PROCESS DURING THE PRIME AND VERIFY STEP DURING SET-UP OF THE COMPOUNDER. IN ORDER TO INVESTIGATE THE ISSUE FURTHER, THE ADD'L FOLLOWING ITEMS WERE EVALUATED: AN EVAL OF THE COMPOUNDER MIXCHECK REPORT INDICATED THAT THE BAGS ARE NOT ASSIGNED TO SPECIFIC PATIENTS AND THAT THE USER IS HITTING THE RUN BUTTON CREATING MULTIPLE BAGS WITH THE SAME SERIAL NUMBER. THE COMPOUNDER BLACK BOX DATA: THIS IS A LOG OF THE COMMANDS THE COMPOUNDER RECEIVES, AND THE ACTIONS THE COMPOUNDER TAKES TO PRODUCT THE SUBJECT BAG. RESULTS AND EVALUATION: THE BLACK BOX DATA FOR THE COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW OF THE BLACK BOX SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUMES OF THE REQUESTED INGREDIENT. UPON FURTHER REVIEW OF THE COMPOUNDER SOFTWARE CONFIGURATION (HOW INGREDIENTS ARE ASSIGNED TO A SPECIFIC PORT AND PUMPING SEQUENCE), IT WAS DETERMINED THAT IT DID NOT MATCH BAXA'S RECOMMENDED SOFTWARE CONFIGURATION. THE CUSTOMER WAS NOTIFIED OF THE DISCREPANCY AND THE BAXA TECHNICAL SUPPORT ASSISTED THE CUSTOMER IN IMPLEMENTING THE CHANGE TO THEIR SOFTWARE CONFIGURATION. BASED ON AN EVALUATION OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE REQUESTED VOLUME OF INGREDIENTS. THIS EVENT WAS CAUSED BY THE USER ATTACHING THE INGREDIENT TO THE INCORRECT PORT ON THE VALVE SET.

    Description of Event or Problem · 1

    IN 2008, BAXA WAS NOTIFIED OF FOUR PATIENTS WHO COMPLAINED OF PAIN AT THEIR IV SIGHT DURING INFUSION OF NORMAL SALINE BAGS COMPOUNDED ON THE COMPOUNDER. (PATIENTS WERE ONLY IDENTIFIED AS PEDIATRIC). THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. BAXA HAS MADE ATTEMPTS TO GATHER FURTHER PATIENT INFO AND WILL CONTINUE TO ATTEMPT TO GET MORE INFO. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO CAN BE OBTAINED FROM THE CUSTOMER. ALL FOUR PATIENT'S BAGS WERE PULLED FROM INFUSION AND SENT TO THE LAB FOR ANALYSIS. ANALYSIS RESULTS SHOWED THAT THE BAGS CONTAINED POTASSIUM CHLORIDE (KCL) AND NOT SODIUM CHLORIDE (NACL) AS ORDERED. UPON REVIEW OF THE COMPOUNDER SETUP, THE PHARMACIST REPORTED THAT THE OPERATOR THAT SET-UP THE COMPOUNDER INADVERTENTLY CONNECTED THE INLET FROM THE INGREDIENT KCL TO THE WRONG PORT OF THE COMPOUNDER VALVE SET, THEREBY INADVERTENTLY PUMPING KCL INSTEAD OF NACL. THE CUSTOMER REPORTED THAT UPON REVIEW OF THEIR COMPOUNDER SETUP STEP OF PRIME AND VERIFY THAT THEY DID NOT VERIFY THE CORRECT PORT ATTACHMENT FOR NACL AND KCL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 600 UNIVERSAL PUMP PHARMACY COMPOUNDING SYSTEM LHI BAXA CORP. 071BR-RS232

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention