BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+3 V11.51 REFR

    MDR report key: 1971402 · Received January 11, 2011

    Report

    Report Number
    2921482-2011-00016
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 22, 2010
    Report Date
    December 16, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K024084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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: "DEVICE WAS DELIVERING CRITICAL DRUG ON CHANNEL C. REPORTER SAW ERROR CODE 403 ON BOTH CHANNELS B AND C. CHANNEL B PREVIOUSLY BEEN PUT IN STANDBY BUT CHANNEL C STOPPED INFUSING. PT'S BLOOD PRESSURE DROPPED WHILE REPLACEMENT PUMP WAS BEING OBTAINED/SETUP. HEALTH PROFESSIONAL'S IMPRESSION: DID NOT CONFIRM REPORTED ERROR CODE BUT CODE E321 LOGGED IN BOTH CHANNEL B AND C AT THE TIME OF OCCURRENCE. THE CODE IS CHARGING CIRCUIT TIME OUT. NO OTHER CODES. CHARGED PUMP OVERNIGHT AND RAN UNTIL LOW BATTERY. OK. REPEATED. VERIFIED OPERATION OF AC RECEPTACLES IN ROOM. OK. LIKELY INTERMITTENT PROBLEM WITH PSU." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED, THE CUSTOMER CONTACTED, REPORTED A DELAY IN THERAPY FOLLOWING AN ALARM CONDITION. CHANNEL C OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF NOREPINEPHRINE AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. CHANNEL B OF THE DEVICE WAS PROGRAMMED WITH AN UNSPECIFIED MEDICATION AND WAS PLACED ON STANDBY. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME, BOTH CHANNELS B AND C REPORTEDLY ALARMED WITH AN ERROR CODE 403. IT WAS REPORTED THAT THE PT'S SYSTOLIC PRESSURE DECREASED INTO THE "50'S". THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. AT AN UNSPECIFIED TIME, THE PT'S BLOOD PRESSURE RETURNED TO "THE NORMAL RANGE" AFTER THERAPY WAS RESUMED. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 V11.51 REFR 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R NOREPINEPHRINE, MFR: UNKNOWN