BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE®

    MDR report key: 8254201 · Received January 16, 2019

    Report

    Report Number
    9681240-2019-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Report Date
    February 25, 2019
    Manufacturer
    B. BRAUN AVITUM ITALY S.P.A.
    Product Code
    LHI
    UDI-DI
    04046964200311
    PMA / PMN Number
    K041222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017. B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN ITALY S.P.A. (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE SET WAS RECEIVED FOR EVALUATION. WHEN THE SET WAS VISUALLY INSPECTED THE REPORTED ISSUE WAS CONFIRMED; THE LEAD LINES WERE REVERSED WITH RESPECT TO THE TUBING SEQUENCE OF THE MANIFOLD. THE CAUSE OF THIS DEFECT WAS A HUMAN ERROR WHICH OCCURRED DURING THE MANUFACTURING PROCESS. AN EMPLOYEE DID NOT USE A POKA-YOKE TOOL THAT WAS DESIGNED TO GUIDE THE ASSEMBLY OPERATOR IN THE CORRECT SEQUENCE OF THE LEAD LINES. RE-TRAINING OF ALL OF THE OPERATORS RESPONSIBLE FOR THIS STEP OF THE ASSEMBLY WAS DONE, IN ORDER TO EMPHASIZE THE IMPORTANCE OF THE CORRECT SEQUENCE OF ASSEMBLY USING THE POKA-YOKE TOOL. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN ITALY S.P.A. (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: TRANSFER SETS ARE LABELED BACKWARDS, FROM LEFT TO RIGHT THE LEADS ARE LABELED 9, 8, 7, 6, 5, 4, 3, 2, 1, INSTEAD OF 1, 2, 3, 4, 5, 6, 7, 8, 9. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47405 PINNACLE® SET, I.V. FLUID TRANSFER LHI B. BRAUN AVITUM ITALY S.P.A. 18G03 04046964200311

    Patients

    Seq Age Sex Outcome Treatment
    1