BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+3 MEDNET WRLSS

    MDR report key: 1971416 · Received January 12, 2011

    Report

    Report Number
    2921482-2011-00020
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 17, 2010
    Report Date
    December 13, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT NUMBER IS (B)(4). THE CUSTOMER CONTACT INDICATED THEY WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CUSTOMER CONTACT INDICATED THAT THE BATTERIES IN THE DEVICE WERE REPLACED AND THE DEVICE WAS RETURNED TO THE CLINICAL SETTING ON (B)(4) 2010. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "E321 MALFUNCTION OF IV PUMP RESULTING IN ALL THREE CHAMBERS OF IV PUMP STOPPING FROM DELIVERING MEDICATION. PT RECEIVING EPINEPHRINE, MILRINONE, PROPOFOL, AND VASOPRESSIN THROUGH THIS IV PUMP. DURING E321 MALFUNCTION, PT'S SYSTOLIC BLOOD PRESSURE DECREASED TO 85MMHG FROM 100MMHG WHILE STAFF OBTAINED AND SWITCHED TO ANOTHER IV PUMP. UPON RESTARTING IV DRIPS, PT'S BLOOD PRESSURE INCREASED TO BASELINE. IV PUMP TAKEN OUT OF SERVICE." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED. IT WAS REPORTED THAT AFTER THE REPORTED EVENT, THE DEVICE WAS SENT TO THE BIOMEDICAL ENGINEERING DEPT. A REVIEW OF THE HISTORY WAS COMPLETED BY THE BIOMEDICAL ENGINEER. THE BIOMEDICAL ENGINEER REPORTED THAT DURING THE EVENT, THE HISTORY INDICATED THE DEVICE WAS OPERATING ON BATTERY POWER AND AT 0412, ALL 3 CHANNELS ALARMED FOR E321 (BATTERY NOT CHARGING). THE CUSTOMER CONTACT STATED THAT WHEN THE DEVICE AS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT, THE BATTERIES ON ALL 3 CHANNELS WERE "COMPLETELY CHARGED." DURING TESTING AT THE USER FACILITY, WHILE OPERATING ON BATTERY POWER, AT AN UNSPECIFIED RATE, FOR 2 HOURS, THE DEVICE ALARMED WITH "WARNING LOW BATTERY" ALARM. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L PT AND EVENT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+3 MEDNET WRLSS 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R MANUFACTURERS: UNKNOWN| EPINEPHRINE| PROPOFOL| MILRINONE| VASOPRESSIN