BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4917197 · Received July 15, 2015

    Report

    Report Number
    2016493-2015-00498
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    July 15, 2015
    Report Date
    June 16, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REQUEST FOR LOG REVIEW HAS BEEN COMPLETED AND THE REPORT OF A MANNITOL OVER-INFUSION WAS CONFIRMED. NO DEVICES ARE EXPECTED TO BE RETURNED. AN INFUSION OF MANNITOL 20% WAS STARTED ON (B)(6) 2015 AT 08:22AM USING A CUSTOM CONCENTRATION OF 165 GRAM/100ML. THE RATE WAS ENTERED AS 206ML/H WITH THE PATIENT WEIGHT AT 165KG RESULTING IN A DOSE OF 2.06 GRAM/KG/H. THE VTBI WAS INCREASED TO 825ML A MINUTE LATER. THE INFUSION COMPLETED AS PROGRAMMED AT 12:28PM ON (B)(6) 2015. THE VOLUME INFUSED (VI) WAS RECORDED AT 829.129ML. A SECOND INFUSION OF THE SAME DRUG WAS STARTED AT 01:48PM ON (B)(6) 2015 BY RESTORING THE PRIOR PARAMETERS AND THEN DECREASING THE RATE TO 35ML/H, (0.35 GRAM/KG/H). TEN MINUTES LATER THE DOSE WAS CHANGED TO 1GRAM/KG/H WHICH INCREASED THE RATE TO 100ML/H. THE INFUSION CONTINUED AT 100ML/H FOR A PERIOD OF 22 HOURS AND 43 MINUTES BEFORE BEING TURNED OFF ON (B)(6) 2015 AT 12:43PM. DURING THE NOTED PERIOD SEVERAL NEW VTBI VALUES WERE ENTERED FOLLOWING EVENTS OF INFUSION COMPLETED. THE RECORDED VI FOR THIS TIME PERIOD WAS 1249.47ML. ON (B)(6) 2015 AT 04:13PM THE SAME PUMP MODULE WAS PROGRAMMED TO INFUSE CALCIUM GLUCONATE 3000MG/150ML AT 300ML/H FOR DURATION OF 30 MINUTES. WHEN THE INFUSION WAS STARTED, AIR-IN-LINE (AIL) ALARMS OCCURRED IMMEDIATELY AND THE USER PERFORMED TYPICAL ACTIONS OF ATTEMPTED RESTARTS AND OPENING OF THE DOOR AND SAFETY CLAMP TO CLEAR THE AIR AND RESTART THE INFUSION. AT 4:46 PM THE DEVICE ALARMED TWICE FOR FLUID SIDE OCCLUSION AND WAS TURNED OFF A MINUTES LATER WITH THE DEVICE HAVING RECORDED A VI OF 148.09ML. A THIRD INFUSION OF MANNITOL 20% WAS STARTED AT 05:57PM ON (B)(6) 2015. THIS INFUSION WAS PROGRAMMED WITH A CUSTOM CONCENTRATION OF 100 GRAM/500ML. THE DOSE WAS ENTERED AS 1 GRAM/KG/H RESULTING IN A RATE OF 825ML/H. THE INFUSION COMPLETED AS PROGRAMMED. A USER ATTEMPTED UNSUCCESSFULLY TO TURN OFF THE DEVICE BUT DID NOT HOLD THE CHANNEL OFF KEY LONG ENOUGH. THE USER THEN RESTORED THE PRIOR INFUSION PARAMETERS AND STARTED THE INFUSION. AN AIL ALARM OCCURRED WITH THE USER OPENING THE SAFETY CLAMP TO CLEAR THEN RESTARTED THE INFUSION WITH A NEW VTBI OF 500ML. THE INFUSION COMPLETED, THE USER ENTERED A NEW VTBI OF 30ML AND CONTINUED THE INFUSION UNTIL 07:06PM ON (B)(6) 2015 WHEN IT WAS TURNED OFF. THE CALCULATED VI FOR THE INFUSION IN THIS TIME PERIOD WAS 836.14ML. ANOTHER INFUSION OF MANNITOL 20% WAS PROGRAMMED WITH THE STANDARD DRUG LIBRARY CONCENTRATION OF 100 GRAM/500ML AT 07:49PM ON (B)(6) 2015. THE DOSE WAS AGAIN ENTERED AS 1 GRAM/KG/H (825ML/H). THE INFUSION RAN FOR A TOTAL DURATION OF 2 HOURS AND 31 MINUTES. DURING THE NOTED PERIOD SEVERAL NEW VTBI VALUES WERE ENTERED FOLLOWING EVENTS OF INFUSION COMPLETED. THE PUMP MODULE WAS TURNED OFF AT 10:20PM ON (B)(6) 2015. THE CALCULATED VI FOR THE INFUSION IN THIS TIME PERIOD IS 1,671.13ML. THE TOTAL CALCULATED VOLUME OF THE DRUG MANNITOL 20% THE PATIENT RECEIVED WITHIN THE TIME PERIOD REVIEWED WAS 3,756.74ML. THE ROOT CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE IS ATTRIBUTED TO PROGRAMMING. NO MALFUNCTION OF A DEVICE WAS ALLEGED OR IS BELIEVED TO HAVE OCCURRED. NO DEVICES RECEIVED, LOG REVIEW ONLY

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER-INFUSION OF MANNITOL WHICH LED TO THE PATIENT DEVELOPING RENAL FAILURE THAT REQUIRED INTERMITTENT HEMODIALYSIS FOR APPROXIMATELY 24 HOURS. ALTHOUGH THE PATIENT ALSO WAS DIAGNOSED WITH INTRACRANIAL HEMORRHAGE, IT WAS NOT CLEAR WHETHER OR NOT THE OVER-INFUSION CONTRIBUTED TO THAT CONDITION. EVENT DETAILS ARE AS FOLLOWS: MANNITOL 100GRAM/500ML (0.2GRAM/ML) WAS STARTED IN THE EMERGENCY ROOM. THE INTENDED DOSE WAS 1 GRAM/KG (165GRAM) TO INFUSE OVER 4 HOURS. AFTER EVALUATION OF INFUSION KNOWLEDGE PORTAL DATA, THE PHARMACIST WAS ABLE TO CONFIRM THAT THE DEVICE HAD BEEN INCORRECTLY PROGRAMMED FOR MANNITOL 165GRAM/100ML (1.65MG/ML) BUT THE RATE WAS INITIALLY ENTERED CORRECTLY THEREFORE THE LOADING DOSE ACTUALLY INFUSED AS INTENDED. HOWEVER, LATER THE PATIENT WAS TRANSFERRED TO ICU AND THE INFUSION WAS RESUMED WITH THE ERRONEOUS CONCENTRATION; REPORTEDLY, THERE WAS A PHYSICIAN ORDER TO "CONTINUE MANNITOL DOSE FROM EMERGENCY ROOM" AND WHEN THE ICU NURSE CONTACTED THE EMERGENCY ROOM TO DETERMINE WHAT THAT DOSE HAD BEEN, IT WAS MISTAKENLY INTERPRETED AS 1MG/KG/H INSTEAD OF 1MG/KG OVER 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460347 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 8015,(2)8100,(3)PRI TUBING, THERAPY DATE (B)(6) 15