BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIFLOW PRIMARY SET CPP, PAV, PREPIERCED Y-SITE

    MDR report key: 759021 · Received September 7, 2006

    Report

    Report Number
    759021
    Event Type
    Death
    Date Received
    September 7, 2006
    Date of Event
    June 29, 2005
    Report Date
    July 20, 2005
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH RECEIVED 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 & HAD BEEN PLACED ON LEVOPHED & 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 RN 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. RN'S GAVE MEDS MANUALLY & ATTEMPTED TO RESUSCITATE PT WHILE ANOTHER RN STARTED WITH A LL NEW BAGS & 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. THE CUSTOMER CONTACT REPORTED THE PT "HAD BEEN DECLINING ALL DAY." AT 0235, THERE WERE IRRESOLVABLE PUMP ALARMS ON 2 PUMPS USING THE SAME TUBING ST. THE PT'S BLOOD PRESSURE WAS DECREASING AND THE PT WAS TREATED WITH EPINEPHRINE & LEVOPHED BOLUSES. THE EPINEPHRINE AND LEVOPHED WERE CONTINUED ON A 3RD PUMP. AT AN UNSPECIFIED TIME THE PT WAS INTUBATED & WENT INTO ASYSTOLE. THE PT EXPIRED AT 0255. THOUGH REQUESTED, NO ADDITIONAL 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