BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O/F 4000 PLUS PMP

    MDR report key: 1352104 · Received March 25, 2009

    Report

    Report Number
    2921482-2009-00105
    Event Type
    Injury
    Date Received
    March 25, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 24, 2009
    Manufacturer
    HOSPIRA, INC.
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING A POWER LOSS. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER LEVOPHED 70MCG/ML. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, WHILE OPERATING AN AC POWER, THE PUMP ALARMED "PUMP FAILURE" AND POWERED OFF. AT THIS TIME, THE PATIENT HAD AN UNSPECIFIED DECREASE IN BLOOD PRESSURE. THE PATIENT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF PHENYLEPHRINE IV PUSH. AFTER AN UNSPECIFIED LENGTH OF TIME, THE THERAPY WAS RESUMED USING THE SAME PUMP. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. AT AN UNSPECIFIED TIME LATER, THE PUMP WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE PUMP PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R LEVOPHED: MANUFACTURER UNK