BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK®

    MDR report key: 6133531 · Received November 29, 2016

    Report

    Report Number
    9614279-2016-00129
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Report Date
    August 21, 2015
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    UDI-DI
    04046964187995
    PMA / PMN Number
    K922637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INC. INTERNAL REPORT # (B)(4). ONE USED SET WAS RECEIVED FOR EVALUATION. THE SET WAS TESTED FOR LEAKAGE PER THE SPECIFICATION, AND THERE WAS LEAKAGE OBSERVED FROM THE TOP CAP OF THE BLOOD FILTER HOUSING. AS THIS IS A PURCHASED PART FROM FILTERTEK, THE SAMPLE AND ALL AVAILABLE INFORMATION REGARDING THIS COMPLAINT WAS SENT TO THE SUPPLIER FOR EVALUATION: SCAN NUMBER (B)(4). IN ORDER TO HELP MITIGATE THE POTENTIAL ROOT CAUSES, FILTERTEK, THE SUPPLIER MODIFIED THE SOLVENT DRYING CARROUSEL CONTROL TO ELIMINATE OCCURRENCES OF UNITS WITH SHORTER DRYING TIMES AFTER ASSEMBLY OF THE FILTER, AND A POKE-YOKE, GO/NO-GO GAGE WAS IMPLEMENTED TO MITIGATE IN-PROCESS ISSUES REGARDING THE TUBING CLOSE TO OR OUT OF SPEC AT THE HIGHER TOLERANCE. THE SUPPLIER ALSO PERFORMED AN ADJUSTMENT OF THE CAROUSEL FIXTURE TO ALSO HELP PREVENT PARTS FROM BEING BENT OR OVER-PRESSED IF THE TUBING IS CLOSE TO THE UPPER SPEC. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: FILTER CHAMBER CRACKED, LEAKING SALINE AND BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783829 OUTLOOK® SET, ADMINISTRATION, INTRA FPA B. BRAUN DOMINICAN REPUBLIC INC. 0061438546 04046964187995

    Patients

    Seq Age Sex Outcome Treatment
    1