BEUDAMED
    FDA Adverse Event Death Summary report: N

    OUTLOOK

    MDR report key: 10362631 · Received August 4, 2020

    Report

    Report Number
    1641965-2020-00013
    Event Type
    Death
    Date Received
    August 4, 2020
    Date of Event
    July 24, 2020
    Report Date
    October 28, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    UDI-DI
    04046964186547
    PMA / PMN Number
    K011975
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER: (B)(4). WHILE THE EVENT DESCRIPTION INDICATES THAT DEATH OF THE PATIENT OCCURRED, THE PATIENT THEMSELVES WERE ALREADY ON PALLIATIVE CARE DUE TO AN INOPERABLE BOWEL OBSTRUCTION. THE EVENT INDICATES THAT 2.5 HOURS AFTER THE ALLEGED FREEFLOW OF MEDICATION, THE PATIENT WAS ADMINISTERED ADDITIONAL MEDICATION AFTER BECOMING AGITATED. AS SUCH, THE CAUSAL LINK BETWEEN THE MALFUNCTION OF THE DEVICE AND THE DEATH OF THE PATIENT IS NOT COMPLETELY CLEAR. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION B. BRAUN HAS ELECTED TO REPORT THIS INCIDENT AS A PATIENT DEATH IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. A PICTURE WAS PROVIDED FOR EVALUATION. THE PICTURE SHOWS THE PUMP BEZEL WITH A MISSING CENTER CASSETTE ALIGNMENT PIN. NEITHER THE DEVICE NOR THE LOGS WERE PROVIDED FOR THIS INVESTIGATION. MULTIPLE SCENARIOS WERE ATTEMPTED TO REPLICATE THE FREE FLOW EVENT USING THE DETAILS PROVIDED BY THE CUSTOMER. IT WAS DETERMINED THAT THE FREE FLOW EVENT WAS NOT CAUSED BY A DEVICE MALFUNCTION. THE MOST PROBABLE ROOT CAUSE WAS ATTRIBUTED TO EXCESSIVE MANIPULATION OF THE SET BY THE USER TO CLOSE THE PUMP DOOR WITHOUT PROPER ALIGNMENT IN CONJUNCTION WITH THE MISSING CENTER PIN. BASED ON THE ORIGINAL DESIGN INFORMATION, THE PULL FORCE REQUIRED TO REMOVE A GUIDE PIN WITHOUT GLUE MEASURED IN POUNDS HAD AN AVERAGE OF 33.6 LBS. WITH THE PIN ASSEMBLED USING GLUE (LOCTITE 495) THE AVERAGE PULL FORCE WAS 120.3 LBS. AN INSPECTION OF EXISTING INVENTORY OF OUTLOOK ES PUMPS (621-400ES), SPARE PARTS AND SUBASSEMBLIES (FZ00501785, FZ00501785R) WAS PERFORMED FOR EVIDENCE OF MISSING OR LOOSE PINS ON THE OUTLOOK ES MAIN BEZEL ASSEMBLY. A TOTAL OF 173 UNITS WERE INSPECTED WITH NO EVIDENCE OF THE FAILURE MODE. A QUALITY ALERT WAS ISSUED WITHIN THE MANUFACTURING FACILITY THAT ADDITIONAL ATTENTION TO INSPECTION IS RECOMMENDED FOR THE PRESENCE AND SECURING OF THE PINS ON REPAIRED PUMPS AND BEZELS BEFORE AND AFTER REPAIR AND BURNING. PER THE OPERATIONS AND SERVICE MANUAL ALL THREE (3) GUIDE PINS MUST BE PRESENT AND SECURED IN THE MAIN BEZEL TO ALLOW PROPER DISPOSABLE SET ALIGNMENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). WHILE THE EVENT DESCRIPTION INDICATES THAT DEATH OF THE PATIENT OCCURRED, THE PATIENT THEMSELVES WERE ALREADY ON PALLIATIVE CARE DUE TO AN INOPERABLE BOWEL OBSTRUCTION. THE EVENT INDICATES THAT 2.5 HOURS AFTER THE ALLEGED FREEFLOW OF MEDICATION, THE PATIENT WAS ADMINISTERED ADDITIONAL MEDICATION AFTER BECOMING AGITATED. AS SUCH, THE CAUSAL LINK BETWEEN THE MALFUNCTION OF THE DEVICE AND THE DEATH OF THE PATIENT IS NOT COMPLETELY CLEAR. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION B. BRAUN HAS ELECTED TO REPORT THIS INCIDENT AS A PATIENT DEATH IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS PER REPORTED BY THE USER FACILITY: THE MIDDLE ALIGNMENT PIN ON THE PUMP WAS MISSING AND THE DRUG (DILAUDID) FREE-FLOWED CAUSING AN OVERINFUSION. THE DOSE WAS SUPPOSED TO BE 1ML/HR AND A FULL 50ML FREE-FLOWED. NO LEAKS OR WET AREAS WERE NOTED SO IT IS BELIEVED THE PATIENT RECEIVED THE MEDICATION. THE PATIENT TOLERATED THE FULL DOSE. THE PUMP ALARMED TO CHECK THE SET THREE TO FOUR TIMES. THE DRIP WAS DISCONTINUED. PATIENT DID HAVE A DROP IN BLOOD PRESSURE AND RESPIRATORY RATE. ABOUT 2.5 HOURS LATER THE PATIENT BECAME AGITATED AND A NEW OPIOID DRIP WAS STARTED ON A DIFFERENT PUMP. THE PATIENT DID PASS AWAY A SHORT TIME LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828507 OUTLOOK PUMP, INFUSION FRN B. BRAUN MEDICAL INC. 621-400ES 04046964186547

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death