BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE

    MDR report key: 10506887 · Received September 9, 2020

    Report

    Report Number
    1641965-2020-00017
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 27, 2020
    Report Date
    October 28, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    NEP
    UDI-DI
    04046964957437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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). THE DEVICE INVOLVED WAS RECEIVED FOR EVALUATION. VOLUMETRICS SEQUENTIAL TESTING WAS PERFORMED OF 111ML/HR FOR 8 STATIONS CONCLUDING WITH 112ML FOR STATION 9 TESTED IN SPEC AT 1000ML +/-2.7% WITH ROTOR 1 FUNCTIONING CORRECTLY. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). 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 LIPID ROTOR 1 IS TURNING WITH NOTHING PROGRAMMED ON STATION 1. AS A RESULT, IT IS PUMPING A SMALL AMOUNT OF LIPIDS IN A NON-LIPID FINAL CONTAINER. THE CUSTOMER DID NOT INDICATE ANY ALARMS WERE SET OFF AND THE FINAL CONTAINER WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971756 PINNACLE SYSTEM/DEVICE, PHARMACY CO NEP B. BRAUN MEDICAL INC. 601184 04046964957437

    Patients

    Seq Age Sex Outcome Treatment
    1