BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 542858 · Received September 3, 2004

    Report

    Report Number
    6000001-2004-01331
    Event Type
    Death
    Date Received
    September 3, 2004
    Date of Event
    August 4, 2004
    Report Date
    August 6, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED DURING A TRAIL OF THE COLLEAGUE CX AND 3CX PUMPS. THREE MEDICATION ERRORS HAD OCCURRED INVOLVING LEVOPHED, NEO-SYNEPHRINE, MILRINONE (PRIMACOR) INFUSING VIA A TRIPLE CHANNEL COLLEAGUE INFUSION PUMP ON ONE PT. THE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH A RIGHT FLANK PAIN AND NAUSEA. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR URINARY TRACT INFECTION AND HYPOTENSION, WITH A DIAGNOSIS OF SEPSIS. REPORTEDLY, THE PT DETERIORATED WITHIN THE NEXT THREE DAYS. THE PT WAS INITIALLY ON A NASAL CANNULA ADVANCED TO A FACE MASK, AND THEN BIPAP, AND THEN TWO DAYS AFTER THEIR ADMISSION, THE PT WAS INTUBATED EMERGENTLY. FIRST DIRP STARTED WAS LEVOPHED IN A "MCG/MIN" MODE ON A CHANNEL A. LEVOPHED CONCENTRATION WAS PROGRAMMED IN THE GUARDIAN SOFTWARE AT TWO CONCENTRATIONS: A REGULAR CONCENTRATION OF 4MG/250ML AND A HIGH CONCENTRATION OF 16MG/250ML, AS PER THE FACILITY'S REQUEST. THE BAG HUNG CONTAINED A CONCENTRATION OF 16MG/250ML; THE CONCENTRATION SELECTED IN THE GUARDIAN BY THE NURSE WAS 4MG/250ML. THE PT RECEIVED INCORRECT DOSE FOR 4 SHIFTS. NEO-SYNEPHRINE WAS HUNG NEXT ON CHANNEL B ALSO IN A "MCG/MIN" MODE. NEO-SYNEPHRINE CONCENTRATION WAS ALSO PROGRAMMED IN THE GUARDIAN SOFTWARE AT TWO CONCENTRATIONS: A REGULAR CONCENTRATION OF 30MG/250ML AND A HIGH CONCENTRATION OF 160MG/500ML. WHILE PROGRAMMING THE INFUSION, THE NURSE SELECTED AND PROGRAMMED AN INCORRECT NEO-SYNEPHRINE CONCENTRATION OF 30MG/250ML WHEN THE DESIRED CONCENTRATION WAS 160MG/500ML. MILRINONE WAS THE LAST OF THE MEDICATION APPLIED. MILRINONE WAS PROGRAMMED IN THE GUARDIAN SOFTWARE INCORRECTLY: INSTEAD OF THE DESIRED CONCENTRATION OF 20MG/100L, MILRINONE WAS PROGRAMMED IN WITH A CONCENTRATION OF 0.2MG/100ML. THE MILRINONE INFUSION WAS STARTED (AT A RATE OF 700ML/HR) AND WITHIN MINUTES, THE PT DEVELOPED SUPRAVENTIRICULAR TACHYCARDIA AND ATRIAL FIBRILLATION WITH A RATE OF 120-210. CARDIOVERSION WAS PERFORMED AND REPEATED SEVERAL TIMES AND THE PT REVERTED TO NORMAL SINUS RHYTHM. IT WAS REPORTED THAT THE PT HAD ARRHYTHMIA PRIOR TO AND AFTER RECEIVING MILRINONE. DURING THE NEXT SHIFT, GIVEN THE PT'S PROFOUND SEPTIC SHOCK, NO RESPONSE TO PRESSORS AND 100% OXYGEN TO MAINTAIN ADEQUATE SATURATION, THE FAMILY DECIDED TO END ALL AGGRESSIVE SUPPORT OTHER THAN COMFORT MEASURES AND THE PT EXPIRED WITHIN TWO HOURS. THE FACILITY STATED MILRINONE OVERDOSE CAUSED SUPRAVENTRICULAR TACHYCARDIA. HOWEVER, THE PT WAS REPORTED TO EXPIRE "FROM SEPSIS" AND NOT FROM MILRINONE. IMMEDIATE CAUSE OF DEATH WAS ESCHERICIA COLI SEPTICEMIA FROM UROSEPSIS. THE PT AND MULTIORGAN SYSTEM FAILURE. THROUGHOUT THE HOSP STAY, THE PT WAS ALSO RECEIVING MULTIPLE DRIPS AND INFUSIONS OF GENTAMICIN, ZOSYN, CIPROFOXACIN, AMIDOARONE, DOBUTAMINE, DILANTIN, ATVAN, FRESH FROZEN PLASMA, AND PACKED RED BLOOD CELLS VIA PERIPHERAL IV AND CENTRAL LINES. THE MEDICAL RECORD DOES NOT IMPLICATE MILRINONE AS THE CAUSE OF DEATH. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death CONTINU-FLO ADMINISTRATION SET. DRUGS - MILRINONE,| NEO0SYNEPHRINE AND LEVOPHED (MFR. UNK), 2004.