BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 100 ES

    MDR report key: 5776798 · Received July 7, 2016

    Report

    Report Number
    1641965-2016-00006
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    March 26, 2016
    Report Date
    June 9, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    PMA / PMN Number
    K01195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B.BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED EVENT WAS NOT CONFIRMED. THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT 11.2ML/HR AND 20.2ML (DL: FENTANYL CONC) AND THE PUMP TESTED WITHIN SPECIFICATIONS. THE LOG WAS REVIEWED FOR THE DATE OF THE REPORTED EVENT. THE LOG REVIEW SHOWS ON (B)(4) 2016 AND 16:31PM (PUMP TIME 4 HOURS 42 MINUTES LATER THAN CURRENT TIME) AN INFUSION START OF 11.2ML/HR AND 80ML (DL: FENTANYL CONC). AT 18:19PM INFUSION WAS PLACED ON HOLD WITH A VOLUME INFUSED OF 20.2ML. NO FURTHER INFUSIONS TOOK PLACE. BASED UPON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4), 1 ITEM. REPORTS OVER INFUSION. OCCURRED (B)(6) 2016. REPORTS PUMP PROGRAMMED FOR 90 ML FENTANYL AT 11 ML/HOUR. REPORTS NOTED BAG WAS EMPTY WHILE PROVING CARE FOR PATIENT 4 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430536 OUTLOOK 100 ES INFUSION PUMP FRN B. BRAUN MEDICAL INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1