BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOSPIRA INFUSION PUMPS

    MDR report key: 3677437 · Received March 10, 2014

    Report

    Report Number
    MW5034907
    Event Type
    Death
    Date Received
    March 10, 2014
    Date of Event
    February 23, 2014
    Report Date
    March 6, 2014
    Manufacturer
    HOSPIRA INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO THE ICU WITH ACUTE RESPIRATORY FAILURE REQUIRING INTUBATION. SHE WAS REQUIRING VASOPRESSOR SUPPORT FOR SUSPECTED SEPTIC SHOCK. ON THE DAY OF HER DEATH, HER VASOPRESSOR REQUIREMENT INCREASED TO THE MAXIMUM DOSE OF LEVOPHED, EPINEPHRINE AND VASOPRESSIN. HOWEVER, SHE CONTINUED TO HAVE HYPOTENSION. SHE ALSO HAD TWO CARDIAC ARRESTS FROM WHICH SHE WAS RESUSCITATED EARLIER ON DURING THE DAY. FINALLY, FOLLOWING THE SECOND CARDIAC ARREST, SHE WAS NOTED TO REQUIRE FURTHER VASOPRESSOR SUPPORT. THE PT'S FAMILY MADE HER A DO NOT RESUSCITATE AFTER THE SECOND CODE. IT WAS NOTED DURING THE FIRST AND SECOND CODE THERE WAS POSSIBLE ISSUES WITH THE IV PUMPS. STAFF RESPONDED TO IV PUMP ALARMS AND OBSERVED READINGS OF "MALFUNCTION" IMMEDIATELY PRIOR TO THE PT CODING THE FIRST TIME. ANOTHER PUMP WAS BROUGHT IN AS THE PT WAS BEING CODED. THE IV TUBING WAS PLACED IN THE PUMP AND AGAIN, THE IV PUMP ALARMED AND THE RN RESPONDED AND OBSERVED THE PUMP READING "MALFUNCTION" AND THE PT CODED AGAIN. THE PT WAS RESUSCITATED BOTH TIMES. DIAGNOSIS OR REASON FOR USE: SEPSIS, SEVERE HYPOTENSION, PNEUMONIA, RESPIRATORY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141971 HOSPIRA INFUSION PUMPS PLUM A+ TRIPLE FRN HOSPIRA INC. 20678
    141972 HOSPIRA INFUSION PUMPS PLUM A+ TRIPLE FRN HOSPIRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death