BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-F 4000 PLUS

    MDR report key: 1950027 · Received December 7, 2010

    Report

    Report Number
    2921482-2010-00957
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 9, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE POWERED OFF BY ITSELF WITH AN INADEQUATE RESPONSE TIME FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, UNSPECIFIED LINES OF THE PUMP WERE PROGRAMMED TO DELIVER LACTATED RINGERS 1000 ML AT RATE OF 20-30 ML/HR, NOREPINEPHRINE 8 MG/250 ML AND EPINEPHRINE 4 MG/250 ML AT UNSPECIFIED RATES, AND THE DELIVERIES WERE STARTED. NO FURTHER PROGRAMMING WAS PROVIDED. ON (B)(6) 2010, THE PT EXPERIENCED SEIZURE ACTIVITY. THE CUSTOMER CONTACT REPORTED THAT THE PT "WAS NOT RETURNING TO HER PRESURGICAL BASELINE NEUROLOGICAL STATUS" AND THE PHYSICIAN ORDERED A CT SCAN. AT APPROXIMATELY 1200, THE PUMP WAS UNPLUGGED FROM THE AC POWER OUTLET AND THE PT WAS TRANSPORTED TO THE CT DEPARTMENT. DURING TRANSPORT, THE PUMP ALARMED FOR "WHAT WAS THOUGHT TO BE A BATTERY TYPE ALARM." THE CUSTOMER REPORTED 15 SECONDS LATER, THE PUMP LOST POWER. THE NURSE PLUGGED THE PUMP INTO THE AC POWER OUTLET IN THE HALLWAY. THE PUMP POWERED ON. THE NURSE CHECKED THE SETTINGS AND RESTARTED THE DELIVERIES. THE CUSTOMER REPORTED THE THERAPIES "WERE NOT INFUSING FOR APPROXIMATELY 15-20 SECONDS." THE NURSE UNPLUGGED THE PUMP BUT STOPPED AT VARIOUS AC POWER OUTLETS EVERY 30-50 FEET UNTIL THE CT DEPARTMENT WAS REACHED. THE NURSE PLUGGED THE PUMP INTO AC POWER. THE PUMP REMAINED IN CLINICAL USE UNTIL THE PT RETURNED TO THE CLINICAL UNIT. AT THIS TIME, THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT INDICATED THERE WAS NO CHANGE IN THE PT'S CLINICAL STATUS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-F 4000 PLUS 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR