BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM XLD 110V L.A.

    MDR report key: 3760678 · Received April 9, 2014

    Report

    Report Number
    9615050-2014-02554
    Event Type
    Death
    Date Received
    April 9, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 10, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.07ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/- 1ML (+/-5%). THE TECHNOLOGY OF THE PLUM XLM LIST #11859 DOES NOT CONTAIN A PUMP HISTORY THAT PROVIDES PAST PROGRAMMED SETTINGS. HOSPIRA IS UNABLE TO CONFIRM THE PROGRAMMING OF THE DEVICE REPORTED BY THE CUSTOMER. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT DELIVER. IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK IN THE INTENSIVE CARE UNIT. ON (B)(6) 2014 AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVERY NOREPINEPHRINE 8MG/117ML, AT A RATE OF 40ML/HR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE PATIENT WAS IN POOR CONDITION AND REQUIRED HIGH DOSE NOREPINEPHRINE DUE TO LOW BLOOD PRESSURE. NO VALUES WERE PROVIDED. ON (B)(6) 2014 AT 0800, IT WAS REPORTED THE PATIENT'S VERY LOW BLOOD PRESSURE PERSISTED. AT THAT TIME, THE INTENSIVIST INCREASE THE DOSE OF NOREPINEPHRINE AND THE DEVICE WAS REPROGRAMMED TO DELIVER AT A RATE OF 50ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 120ML, FOR A DURATION OF 2 HOURS. AT 0900, IT WAS REPORTED A SECOND UNSPECIFIED DEVICE WAS PROGRAMMED TO DELIVER VASOPRESSIN 4 VIALS/76ML, AT A RATE OF 4ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT THAT TIME, IT WAS REPORTED THE NURSE ASSISTANT NOTED NOTHING UNUSUAL WITH THE DELIVERY OF NOREPINEPHRINE ON THE FIRST DEVICE. BETWEEN 0930 AND 0945, IT WAS REPORTED THE NURSE ASSISTANT WENT TO CHANGE THE NOREPINEPHRINE CONTAINER AND NOTED THERE WAS 80ML LEFT IN THE CONTAINER INSTEAD OF THE EXPECTED ALMOST EMPTY CONTAINER. THE CUSTOMER CONTACT REPORTED THERE WERE NO DEVICE ALARMS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. AT 1000, IT WAS REPORTED THE PATIENT BLOOD PRESSURE WAS 50/35MMHG WITH A MEAN ARTERIAL PRESSURE 40MMHG. THE PATIENT WAS TREATED BY INCREASING THE NOREPINEPHRINE RATE TO 55ML/HR AND THE VASOPRESSIN DELIVERY RATE TO 6ML/HR. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT BLOOD PRESSURE INCREASED TO 125MMHG. AT 1040, IT WAS REPORTED THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. NO SPECIFIC EVENT DETAILS WERE PROVIDED. THE CUSTOMER REPORTED THE CAUSE OF DEATH WAS CARDIAC ARREST. NO AUTOPSY WAS PERFORMED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212913 PLUM XLD 110V L.A. 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death NOREPINEPHRINE, UNK MFR| PLUMSET, LIST #UNK, LOT #UNK