BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2117131 · Received June 8, 2011

    Report

    Report Number
    1314492-2011-00025
    Event Type
    Death
    Date Received
    June 8, 2011
    Date of Event
    November 1, 2010
    Report Date
    May 24, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CALL, THE CUSTOMER STATED THE FOLLOWING: THE PUMP DID NOT MALFUNCTION AND WAS NOT AT FAULT. THE OVERINFUSION WAS DUE TO A HUMAN PROGRAMMING ERROR. THERE WERE MANY FACTORS INVOLVED WHICH RESULTED IN THE PT'S DEATH. THIS INCLUDES CLINICIAN CONFUSION REGARDING WEIGHT VERSUS KG. (DRUG WAS DOSED IN KG), AND CONFUSION IN DOSE MODE PROGRAMMING ON THE PUMP. INCORRECT DOSE VALUES WERE ENTERED IN THE RATE (ML/HR) FIELD. THE INFUSION CONTINUED FOR THREE DAYS WITH ADJUSTMENTS UP AND DOWN BEFORE THE ERROR WAS FOUND, AND THE PT SLOWLY EXSANGUINATED, EVEN AS SHE WAS BEING MONITORED WITH BLOOD TESTS. HARD LIMITS WERE NOT APPLIED TO THIS DRUG, SOFT LIMITS ONLY WERE AVAILABLE AND OVERRIDDEN BY THE CLINICIANS INVOLVED. THERE WAS NO NOTIFICATION TO SIGMA THAT THIS INCIDENT OCCURRED UNTIL THIS CALL TO SIGMA ON (B)(6) 2011. NO INFORMATION ON THE SERIAL NUMBER OF THE PUMP WAS PROVIDED AND THE PUMP IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. IF THE PUMP IS RECEIVED IN THE FUTURE, AN INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    SIGMA RECEIVED A TELEPHONE CALL ON (B)(6) FROM THE HOSPITAL SMART PUMP ADMINISTRATOR, STATING A PT OVER INFUSED WITH LEPIRUDIN, AN ANTI-COAGULANT DRUG. THE PT EXPIRED BY EXSANGUINATION. AN ONLINE SEARCH CONDUCTED FOLLOWING THE REPORTING OF THE EVENT TO SIGMA REVEALED AN ARTICLE ON (B)(6) POSTED ON (B)(6) 2011 REGARDING THE EVENT WHICH INDICATED THAT THE PT BROKE HER SHOULDER SOMETIME IN SEPTEMBER AND WAS UNDERGOING REHABILITATION. SHE WAS ADMITTED TO MGH ON (B)(6) 2010 AFTER DEVELOPING URINARY TRACT INFECTION. DOCTORS AT THE HOSPITAL DECIDED TO ADMINISTER LEPIRUDIN AS AN ANTI-COAGULANT DURING THE COURSE OF HER STAY. THE NURSE ACCIDENTLY ENTERED THE WRONG DOSAGE ON THE IV PUMP WHICH WAS NOT DISCOVERED BY THE STAFF UNTIL LATER. THIS EXCESSIVE DOSAGE OF LEPIRUDIN CAUSED THE PT HEMORRHAGE INTERNALLY FOR 12 HOURS AND DIED. THE ARTICLE ALSO INDICATED THAT THE PT'S FAMILY WAS REPORTED BY THE HOSPITAL OFFICIALS THAT THE PT DIED OF A PREVENTABLE MEDICAL ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA LLC 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death