BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTAMIX® COMPOUNDER

    MDR report key: 2367639 · Received December 12, 2011

    Report

    Report Number
    1419106-2011-00017
    Event Type
    Death
    Date Received
    December 12, 2011
    Date of Event
    November 14, 2011
    Report Date
    November 14, 2011
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SENT IN THE MIXCHECK' REPORT FOR THE TPN BAG THAT WAS MANUFACTURED. IT INDICATES THAT THE EM2400 OPERATED AS DESIGNED BY STOPPING OPERATION AND ALERTING THE USER THAT A BUBBLE WAS DETECTED. THE MIXCHECK REPORT INDICATES THAT THE USER RECEIVED SEVEN BUBBLE ALERTS AND DID NOT STOP PRODUCTION. FAILURE TO FOLLOW INSTRUCTIONS. DEVICE OPERATED ACCORDING TO SPECIFICATIONS. DEVICE NOT RETURNED. .TRAINING DEFICIENCY. USER CAUSED EVENT. MIXCHECK REPORT: PROVIDES DETAILS ABOUT THE COMPOUNDING PROCESS FOR AN ORDER. I REPORTS INFORMATION INCLUDING THE EXPECTED BAG WEIGHT, MEASURED BAG WEIGHT, ORDERED INGREDIENTS AND VOLUMES, AND MANUAL ADDITIONS THAT ARE REQUIRED. IT ALSO REPORTS DETAILS SUCH AS BAG TYPE SELECTED AND ALERTS THAT OCCURED DURING THE PUMPING OF THE BAG (I.E.: BUBBLE ALARMS). BUBBLE DETECTOR: A SAFETY DEVICE THAT DETECTS AIR BUBBLES IN THE TUBING, INDICATING THAT AIR WAS DRAWN INTO THE LINE AND A DECREASED DELIVERY OF THE INGREDIENT COULD RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6), DIRECTOR OF PHARMACY, CONTACTED BAXA TECHNICAL SUPPORT TO REPORT THAT AN ADULT PATIENT WITH TERMINAL CANCER WAS NOT DELIVERED KPHOS IN THEIR TPN COMPOUNDED BY THE BAXA EM2400 COMPOUNDER. THE PATIENT WAS GIVEN A BOLUS OF KPHOS AS A MEDICAL INTERVENTION, BUT DIED THE NEXT DAY. (B)(6) MADE IT CLEAR THAT THE TPN THE PATIENT RECEIVED WAS FOR MAINTENANCE ONLY AND THE LACK OF KPHOS IN THE TPN DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. INVESTIGATION BY BAXA TECHNICAL SUPPORT DETERMINED THAT DURING THE DAILY SET UP OF THE PUMP, THE USER INSTALLED THE KPHOS ON AN INCORRECT PORT (PORT 15) RATHER THAN THE PORT IS WAS SUPPOSED TO BE INSTALLED ON (PORT 17). THE KPHOS BEING ON THE WRONG PORT WAS ALSO MISSED DURING THE PRIME AND VERIFY SECTION OF THE PUMP SET UP. DURING PRIME AND VERIFY, A PHARMACIST CHECKS THE PUMP'S PHYSICAL SET UP, MAKING SURE THE CORRECT INGREDIENT IS ATTACHED TO THE CORRECT PORT, THEN EACH INGREDIENT AND INLET IS SCANNED, AND THEN EACH INLET IS INDIVIDUALLY PRIMED, WITH THE PHARMACIST WATCHING TO MAKE SURE THE CORRECT INGREDIENT IS PUMPED. WITH THE KPHOS BEING ATTACHED TO THE WRONG PORT, THE PUMPED PERFORMED AS DESIGNED AND GAVE A BUBBLE ALARM WHEN IT DETECTED AIR IN THE LINE WHEN THE KPHOS WAS SUPPOSED TO HAVE PUMPED; THERE WERE A TOTAL OF SEVEN BUBBLE ALARMS THAT OCCURRED DURING THE PUMPING OF THIS TPN, AND EACH WAS OVERRIDDEN BY THE PUMP OPERATOR. A REVIEW OF THE MIXCHECK' REPORT CONFIRMED THAT THERE WERE SEVEN BUBBLE ALARMS THAT WERE OVERRIDDEN DURING THE PUMPING OF THE TPN, HOWEVER, THIS WAS NOT ACKNOWLEDGED BY THE PHARMACY OR PHARMACIST AND THE TPN WAS INFUSED. BAXA CORPORATION HAS NOTIFIED THE CUSTOMER OF THE RISKS ASSOCIATED WITH NOT ADEQUATELY COMPLETING THE PRIME AND VERIFY SEQUENCE. (B)(6) HAS ACKNOWLEDGED THAT SHE IS GOING TO EDUCATE HER USERS ABOUT BUBBLE ALARMS AND TO LOOK FOR AIR IN THE SYSTEM WHEN THEY RECEIVE THEM; SHE IS ALSO GOING TO EDUCATE THEM ABOUT CONFIRMING THE CORRECT INGREDIENTS ARE CONNECTED TO THE CORRECT PORT DURING THE PRIME AND VERIFY SECTION OF THE PUMPS' SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX® COMPOUNDER SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXA CORPORATION EM2400-M

    Patients

    Seq Age Sex Outcome Treatment
    1 SYSTEM/DEVICE, PHARMACY COMPOUNDING