BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIFLOW PRIMARY SET CPP, PAV, PREPIERCED Y-SITE

    MDR report key: 744801 · Received July 20, 2005

    Report

    Report Number
    9613251-2005-00059
    Event Type
    Death
    Date Received
    July 20, 2005
    Date of Event
    June 29, 2005
    Report Date
    July 20, 2005
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH REC'D WHICH INDICATED A DELAY OF CRITICAL THERAPY DURING AN ALARM CONDITION AND STATED THE FOLLOWING: "PT WITH TERMINAL METASTATIC CANCER HAD BEEN DETERIORATING DURING THE PRIOR 24 HOUR PERIOD AND HAD BEEN PLACED ON LEVOPHED AND EPINEPHRINE. EARLIER THAT SAME 24 HOUR PERIOD, AN ALARM OCCURRED WITH THIS DEVICE WHICH NOTIFIED RN OF EITHER AN UPSTREAM OCCLUSION OR A FULL COLLECTION BAG. THE PUMP STOPPED RUNNING WHILE RUN ATTEMPTED TO CORRECT THE ALARM STATUS. THIS OCCURRED 10 TIMES IN A SPAN OF 5 MINUTES, DURING WHICH TIME A 2ND PUMP WAS BROUGHT. THE 2ND PUMP SHOWED THE SAME ALARM CONDITION. RNS GAVE MEDS MANUALLY AND ATTEMPTED TO RESUSCITATE PT WHILE ANOTHER RN STARTED WITH ALL NEW BAGS AND TUBING TO PRIME A 3RD PUMP. THIS WAS SUCCESSFUL IN TERMS OF GETTING A PUMP TO WORK, BUT WAS NOT SUCCESSFUL FOR THE PT, HE DIED. TOTAL TIME FROM 1ST ALARM TO DEATH OF PT EQUALS 20 MINUTES." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED: THE PT WAS RECEIVING "MAINTENANCE SOLUTION" ON LINE A AT A RATE OF 75ML/HR, EPINEPHRINE ON LINE B AT A RATE OF 83ML/HR AND LEVOPHED ON LINE C AT A RATE OF 55.3ML/HR VIA A CENTRAL LINE. THE CUSTOMER CONTACT REPORTED THE PT "HAD BEEN DECLINING ALL DAY." AT 0235, THREE WERE IRRESOLVABLE PUMP ALARMS ON 2 PUMPS USING THE SAME TUBING SET. THE PT'S BLOOD PRESSURE WAS DECREASING AND PT WAS TREATED WITH EPINEPHRINE AND LEVOPHED BOLUSES. THE EPINEPHRINE AND LEVOPHED WERE CONTINUED ON A 3RD PUMP. AT AN UNSPECIFIED TIME, THE PT WAS INTUBATED AND WENT INTO ASYSTOLE. THE PT EXPIRED AT 0255. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFLOW PRIMARY SET CPP, PAV, PREPIERCED Y-SITE ADMINISTRATION SET FPA HOSPIRA, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death OMNIFLOW 4000 PLUS, LIST #40051| OMNIFLOW 4000 PLUS, LIST #40051