BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNI-FLOW MODEL 4000 PLUS

    MDR report key: 1181463 · Received September 30, 2008

    Report

    Report Number
    2921482-2008-00307
    Event Type
    Death
    Date Received
    September 30, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 3, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY DURING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, LINE A WAS PROGRAMMED TO DELIVER AN UNSPECIFIED IV FLUID. UNSPECIFIED LINES WERE PROGRAMMED TO DELIVER EPINEPHRINE AT A RATE OF .20MCG/KG/MIN, AND PRIMACOR AND VASOPRESSIN AT UNSPECIFIED RATES. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 2015, THE CUSTOMER CONTACT REPORTED THAT THE PT WAS TRANSPORTED FROM SURGERY TO THE SURGICAL INTENSIVE CARE UNIT IN "CRITICAL STATUS" WITH A BLOOD PRESSURE OF "98/55." AT 2130, THE PUMP SOUNDED AN AUDIBLE ALARM TONE. DURING THE ALARM CONDITION, THE NURSE NOTED THE PT'S BLOOD PRESSURE HAD DECREASED TO "30" SYSTOLIC. THE PT WAS TREATED WITH "MULTIPLE DOSES" OF EPINEPHRINE VIA IV BOLUS. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED WITHIN "3 TO 4 MINUTES," THERAPY WAS RESUMED USING A REPLACEMENT PUMP. AT 2135, THE VASOPRESSIN WAS INCREASED TO AN UNSPECIFIED RATE. AT 2155, CARDIOPULMONARY RESUSCITATION WAS INITIATED. IT WAS REPORTED THAT DURING THE RESUSCITATION, THE SURGEON INITIATED INTERNAL CARDIAC MASSAGE AND INSERTED A BALLOON PUMP. AT 2330, THE PT WAS RETURNED TO THE OPERATING ROOM FOR EXPLORATORY SURGERY. IN 2008 AT 0030, THE PT RETURNED TO THE SICU UNCONSCIOUS, WITH FIXED AND DILATED PUPILS. IT WAS REPORTED, AT 1623, THE PT WAS REMOVED FROM LIFE SUPPORT AT THE FAMILY'S REQUEST AND AT 1648, THE PT EXPIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-FLOW MODEL 4000 PLUS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death EPINEPHRINE| VASOPRESSIN| PRIMACOR