BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2626339 · Received June 20, 2012

    Report

    Report Number
    2016493-2012-00266
    Event Type
    Death
    Date Received
    June 20, 2012
    Date of Event
    May 20, 2012
    Report Date
    May 21, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REQUESTED LOG REVIEW HAS BEEN COMPLETED AND THE REPORTED OVER INFUSION WAS CONFIRMED. A REVIEW OF THE ASSOCIATED PCU EVENT LOG FOR THE PHENYLEPHRINE INFUSION INDICATED THAT THE INFUSION WAS PROGRAMMED AT 12:22 AM ON (B)(6) 2012, AS A CUSTOM CONCENTRATION INFUSION WITH THE DRUG AMOUNT ENTERED AS 320 MCG BUT THE DILUENT ENTERED AS 25 MLS WHICH RESULTED IN A CONCENTRATION OF 12.84 MCG/ML INSTEAD OF THE INTENDED CONCENTRATION OF 320 MCG/ML. THIS ERROR IN PROGRAMMING RESULTED IN A FLOW RATE OF 469 ML/HR INSTEAD OF WHAT SHOULD HAVE BEEN 18.8 ML/HR WHEN THE DOSE WAS SET TO 100 MCG/MIN. THE LOG REVIEW INDICATED THAT THE DOSAGE WAS SUBSEQUENTLY INCREASED TO 150 MCG/MIN (703 ML/HR) AND THEN TO 200 MCG/MIN (938 ML/HR) AND THAT THE INFUSION RAN FOR 26 MINUTES DELIVERING THE PROGRAMMED 250 MLS. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS DETERMINED TO BE THE RESULT OF USER PROGRAMMING.

    Description of Event or Problem · 1

    BIOMED REPORTED A PATIENT DEATH THAT MAY HAVE RESULTED FROM AN OVERINFUSION. THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO TRAUMA. PHENYLEPHRINE 320 MCG/ML IN A 250 ML BAG WAS HUNG BUT ACCORDING TO HIS REVIEW OF THE EVENT LOG WITH THE PHARMACIST, IT APPEARS THE USER PROGRAMMED THE CONCENTRATION AS 320 MCG/25 ML DILUENT VOLUME. HE DOES NOT KNOW THE INTENDED PROGRAMMING, BUT SAYS THIS ERROR RESULTED IN AN INFUSION RATE OF 703 ML/HR, RESULTING IN THE BAG EMPTYING IN 40 MINUTES. DURING THIS TIME HIS REVIEW OF THE LOGS SHOWS THERE WERE 4 OCCLUSION ALARMS. AT SOME POINT THE USER REPROGRAMMED THE INFUSION RESULTING IN A CALCULATED RATE OF 937 ML/HR. BECAUSE OF THE PATIENT'S UNDERLYING TRAUMA THEY ARE NOT SURE WHETHER THE OVERINFUSION CAUSED THE DEATH. CUSTOMER IS REQUESTING A LOG REVIEW TO CONFIRM THE SUSPECTED PROGRAMMING ERROR. ADDITIONAL INFORMATION: "THE PATIENT WAS ADMITTED FOLLOWING A SEVERE TRAUMA WITH LOW BLOOD PRESSURE. A VERBAL ORDER WAS PLACED TO BEGIN PHENYLEPHRINE AT 100 MCG/MIN. THE MED WAS OBTAINED FOR AN AUTOMATED DISPENSING CABINET AND STARTED ON THE PUMP (THIS IS A 320 MCG/ML - 250 ML BAG WHICH IS WHAT WAS BEING USED). IT APPEARS THAT THE WILD CARD FOR PHENYLEPHRINE INSTEAD OF THE STANDARD CONCENTRATION WAS SELECTED. THE NURSE SUBSEQUENTLY INCREASED THE DOSE ON 2 OCCASIONS, FIRST TO 150 MCG/MIN AND THEN TO 200 MCG/MIN. AFTER APPROXIMATELY 45 MINUTES, THE BAG WAS EMPTY AND THE ENTIRE 250 ML HAD INFUSED. AT THAT TIME, PHARMACY WAS CALLED TO INVESTIGATE THE PUMP AND IT WAS NOTED THAT THE PUMP WAS RUNNING AT A RATE OF 938 ML/HOUR (PROGRAMMED FOR A DOSE OF 200 MCG/ML BUT WITH A CONCENTRATION OF 12.8 MCG/ML (FROM ENTERED AMOUNTS OF 320/25 WHILE PROGRAMMING THE WILD CARD)." PROFILE ICU/ED. PROGRAMMED INITIALLY AT 100 MCG/MIN INCREASING TO 200 MCG/MIN. PATIENT INITIALLY HAD SLIGHT RESPONSES TO THERAPY, BUT THEN ARRESTED AND DIED SEVERAL HOURS LATER. CUSTOMER STATED NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death ALARIS PC UNIT: SN (B)(4)| THERAPY DATE:| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT # UNKNOWN