BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 1954611 · Received December 15, 2010

    Report

    Report Number
    2921482-2010-01010
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 29, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: MANDATORY USER FACILITY MEDWATCH REPORT WAS REC'D ON 12/09/2010. (B)(4). THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH REC'D THAT STATED: "PT WAS RECEIVING DIPROVAN 2ML/HOUR. INFUSION HAD BEEN RUNNING FOR 1 HOUR WHEN PT'S BP DROPPED (32/11). PT WAS ALREADY INTUBATED AND WAS BEING BAGGED. APPROX 15 MINUTES LATER, IV PUMP ALARM SOUNDED. IT WAS NOTED THAT DIPROVAN BOTTLE WAS HALF GONE. PUMP SHOWED ERROR OF "OPERATING WHILE DOOR OPEN," BUT DOOR WAS NOT OPEN. INFUSION STOPPED IMMEDIATELY. PUMP HAD NO OTHER INFORMATION ON SCREEN. NURSE ESTIMATED THAT PT REC'D 500MG DIPROVAN OVER 15 MINUTES TIME FRAME." UPON FURTHER QUERY THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED THE PT REC'D MORE MEDICATION THAN INTENDED. AT 1248, THE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH A BLOOD PRESSURE (BP) OF 90/61 MMHG. AT 1400, THE DEVICE WAS PROGRAMMED TO DELIVER DIPROVAN 1000MG/100ML, AT A RATE OF 2ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 100ML, AND A DURATION OF 1.5 HRS. AT THIS TIME, THE PT'S BP WAS 53/20 MMHG. AT 1500, THE PT'S BP DECREASED TO 32/11 MMHG. THE PHYSICIAN WAS NOTIFIED. THE PT WAS TREATED WITH A BOLUS OF UNSPECIFIED HYDRATION FLUIDS. THE CUSTOMER CONTACT REPORTED THAT THE PT WAS ALSO RECEIVING AN UNSPECIFIED CONCENTRATION OF LEVOPHED AND THE DELIVERY WAS INCREASED TO AN UNSPECIFIED HIGHER RATE. AT 1515, THE DEVICE ALARMED FOR N250 (DOOR OPEN WHILE PUMPING). AT THIS TIME, THE NURSE NOTED THAT ONLY 500MG OF DIPRIVAN REMAINED IN THE CONTAINER. THE DEVICE WAS POWERED OFF. AT 1600, THE PT'S BP WAS 104/52 MMHG AND THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AT AN UNSPECIFIED TIME, THERAPY WAS RESUMED USING A PLACEMENT DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R SN (B)(4)| DIPRIVAN| MFR BY NOVA PLUS/EPP PHARMACEUTICALS| PLUM A+ SOFTWARE MODULE, LIST # 12097