BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ 3 MEDNET SW

    MDR report key: 2135044 · Received June 7, 2011

    Report

    Report Number
    9615050-2011-00426
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    December 31, 2010
    Report Date
    May 9, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    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

    (B)(4) WAS RECEIVED FROM CDRH THAT STATED THE FOLLOWING: "THE PT'S NURSE WAS ABSOLUTELY SURE THAT SHE HAD PROGRAMMED THE PUMP AT 0.7MCG/KG/HR, BUT WHEN SHE WENT BACK TO CHECK ON THE PT THE PUMP SOMEHOW WAS INFUSING ALL THE MEDICATION - PRECEDEX - WITHIN MINUTES. THE NURSE LOOKED AT THE PUMP WHEN IT FINISHED AND IT SHOWED THAT THE PUMP WAS RUNNING 10MCG/KG/HR." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED THE DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN THE ORIGINALLY PROGRAMMED RATE. AT AN UNSPECIFIED TIME, LINE A OF CHANNEL 3 WAS PROGRAMMED TO DELIVER PRECEDEX 200MCG/50ML, AT AN UNSPECIFIED RATE, FOR A DOSE OF 0.7MCG/KG/MIN AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX 15 MINUTES, THE NURSE NOTED THAT THE PRECEDEX CONTAINER WAS EMPTY AND THAT THE DOSE WAS DISPLAYED AS 10MCG/KG/MIN. AT THIS TIME, THE NURSE NOTED THE PT'S BLOOD PRESSURE INCREASED FROM 130/50MMHG TO 150-190/60'S MMHG. THE PHYSICIAN WAS NOTIFIED. THE PRECEDEX WAS HELD FOR APPROX 2 HOURS AND THE PT'S BLOOD PRESSURE DECREASED TO 130-140/60-70 MMHG. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. DURING TESTING AT THE USER FACILITY, CHANNEL 3 OF THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ 3 MEDNET SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PRECEDEX, MFG BY HOSPIRA, INC.