BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-F 4000 PLUS

    MDR report key: 1991005 · Received February 10, 2011

    Report

    Report Number
    9615050-2011-00068
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 14, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY DURING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, LINE A WAS PROGRAMMED TO DELIVER NORMAL SALINE AND UNSPECIFIED LINES WERE PROGRAMMED TO DELIVER UNSPECIFIED "PRESSORS." NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT 10 MINUTES AFTER THE DELIVERY WAS STARTED, THE DEVICE ALARMED FOR OCCLUSION IN LINE A. DURING THE ALARM CONDITION, THE DELIVERIES ON ALL LINES WERE STOPPED, INCLUDING THE "PRESSORS." THE CUSTOMER CONTACT REPORTED THAT A "SMALL KINK" AT AN UNSPECIFIED LOCATION WAS NOTED IN THE TUBING SET ON LINE A. AT THIS TIME, THE PATIENT'S BLOOD PRESSURE "FELL SUDDENLY" TO AN UNSPECIFIED LEVEL. THE CUSTOMER CONTACT STATED THAT REPLACEMENT DEVICE WAS AVAILABLE TO DELIVER UNSPECIFIED CONCENTRATION OF LEVOPHED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS INITIATED USING THE REPLACEMENT DEVICE. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, EVENT DETAILS, AND PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NORMAL SALINE: MANUFACTURER UNK| UNSPECIFIED "PRESSORS": MANUFACTURER UNK| OMNI-FLOW TUBING SET: LIST# UNK, LOT# UNK