BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ 11.6 BRAZIL

    MDR report key: 3150090 · Received May 31, 2013

    Report

    Report Number
    9615050-2013-01453
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF NORADRENALINE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE NURSE NOTED THAT THE PATIENT WAS HYPOTENSIVE. NO SPECIFIC VALUES WERE PROVIDED. AT THAT TIME, THE NURSE NOTED THE DEVICE POWERED OFF BY ITSELF WITHOUT SOUNDING AN AUDIBLE ALARM TONE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED, INCLUDING IF ANY MEDICAL INTERVENTIONS WERE REQUIRED, PATIENT OUTCOME, AND IF THERAPY WAS RESUMED USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240400 PLUM A+ 11.6 BRAZIL 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST # 12097