BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA

    MDR report key: 2574871 · Received May 8, 2012

    Report

    Report Number
    MW5025351
    Event Type
    Death
    Date Received
    May 8, 2012
    Date of Event
    March 26, 2012
    Report Date
    May 8, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MR. (B)(6) HAD REDO CAB AVR SURGERY AT (B)(6), (B)(6) 2012. HE RETURNED TO THE CARDIAC INTENSIVE CARE UNIT ON AN EPINEPHRINE DRIP RUNNING BY A SIGMA PUMP. DR. (B)(6) FROM ANESTHESIA HAD HAD THIS PUMP SET AT A 2 MICROGRAM RATE ON LEAVING THE OPERATING ROOM. ON ARRIVAL TO THE UNIT THE IV INFUSION RATE WAS 150 CC/MINUTE OF THE STANDARD MIXTURE OF EPINEPHRINE EQUIVALENT TO ABOUT 40 MICROGRAMS PER MINUTE. THE PATIENT WAS HYPOTENSIVE AND SEVERELY ACIDOTIC. THIS WAS CORRECTED WITH BICARB INFUSION AND RESETTING THE EPI TO 2 MICROGRAMS. THE PATIENT CONTINUED TO IMPROVE OVER THE NEXT SEVERAL DAYS. HAD REMAINED EXTUBATED BUT WITH A BALLOON PUMP IN PLACE. HE HAD AN UNEXPECTED EPISODE WITH CARDIAC ARREST WHILE TALKING TO HIS WIFE SEVERAL DAYS LATER. I HAVE NO PRIOR KNOWLEDGE OF AN ADVERSE EVENT WITH THESE SIGMA PUMPS, HOWEVER, IN SPEAKING WITH THE NURSES REGARDING THIS, THEY EXPRESSED A CERTAIN FRUSTRATION. THEY HAVE BEEN NOTING A PROBLEM WITH THESE PUMPS. WHEN THEY ARE PROGRAMMED IT IS ALLEGED AT A RATE THEY OFTEN HAVE A MIND OF THEIR OWN AND SWITCH TO MICROGRAMS AT THE NUMBER PROGRAMMED IN AS ML WITHOUT WARNING. THE NURSES SAID THAT THIS HAS CAUSED SOME "NEAR MISSES", PARTICULARLY WITH THE USE OF ANTI HYPERTENSIVE AGENTS SUCH AS NIPRIDE, WHERE THEY HAVE PROGRAMMED IN ML FOR ANTIHYPERTENSIVE TREATMENT ONLY TO FIND THE DOSE 4-5 TIMES HIGHER WITH SUDDEN OVERSHOOT WITH SEVERE TRANSIENT HYPOTENSION RESULTING FROM THE UNEXPECTED "SWITCH" BY THE PUMP TO A HIGHER DOSE. (B)(6) POSTED A WARNING/RECALL NOTICE ON ITS PHYSICIANS MEDICAL WEB PAGE (B)(6) 2011 NOTIFYING PHYSICIANS OF THE RECALL OF SIGMA PUMPS AND STATE "SIGMA INDICATES FAILURE RATE...(B)(6)..." AND "(B)(6) HAS NOT EXPERIENCED ANY ISSUES REGARDING ITS IV PUMPS AND WE ARE FOLLOWING THE MANUFACTURER'S RECOMMENDATIONS AS WELL AS REMAINING VIGILANT." NURSES STATE THAT THEY HAVE SUBSEQUENTLY REPORTED PROBLEMS LIKE THIS WITH THESE PUMPS SINCE THEY WERE INSTALLED HOSPITAL WIDE, AND THEY STATED THAT WHEN THEY HAVE COMPLAINED TO NURSING ADMINISTRATION, THEY HAVE BEEN TOLD "GET OVER IT, THE REAL WORLD LIVES IN MICROGRAMS" AND SOME HAVE EXPRESSED FEAR OVER THEIR JOBS IF THEY WERE TO COMPLAIN TOO MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA IV PUMPS FRN SIGMA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L