BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET 20 DP, W/ FILTER Y SITE

    MDR report key: 10939506 · Received December 3, 2020

    Report

    Report Number
    9616066-2020-20510
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    September 22, 2020
    Report Date
    December 22, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00814371020075
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS REPORTED A2-80071-DF-ADMIN SET 20 DP, W/ FILTER Y SITE-NA, THAT AN ADMINISTRATION SET MODEL WAS LEAKING AT THE FILTER. SAMPLE OR PHOTOS WERE NOT PROVIDED BY THE CUSTOMER, THE LEAK FAILURE MODE COULD NOT BE CONFIRMED ON THE MODEL A2-80071-DF. A GEMBA WALK WAS CARRIED OUT TO IDENTIFY POSSIBLE FINDINGS IN THE MANUFACTURING PROCESS ACCORDING TO THE OPERATIONS FLOW OF THE MODEL A2-80071-DF. NO OPPORTUNITIES WERE FOUND IN THE PRODUCTION PROCESS FOR THE MODEL A2-80071-DF AFTER THE GEMBA WALK WAS PERFORMED AND THE POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED SINCE THE FAILURE MODE WAS NOT CONFIRMED. ALSO, THE LEAK IS REPORTED IN THE FILTER, IT IS PROVIDED BY THE SUPPLIER, BUT TJ MANUFACTURING CANNOT GUARANTEE THAT IT IS A SUPPLIER RELATED FAILURE MODE BECAUSE THERE ARE SOME FACTORS THAT CAN LEAD TO THIS FAILURE MODE (IF IS FOR A DAMAGE, RAW MATERIAL, BADLY SEALED, HANDLING IN THE PROCESS, ETC.). TO DETECT LEAK FAILURE MODE, THE PCP PERSONNEL PERFORM LEAK TESTS TO THE MODEL PRODUCED ACCORDING TO THE ATP-007 TP, PRODUCT LEAK TAHITI-10000004835. DHR REVIEW MODEL : A2-80071-DF, LOT: 20036759, NO QNS WERE FOUND IN THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ADMIN SET 20 DP, W/ FILTER Y SITE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: A2-80071-DF, BATCH NO: 20036759. IT WAS REPORTED THAT AN ADMINISTRATION SET MODEL WAS LEAKING AT THE FILTER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADMIN SET 20 DP, W/ FILTER Y SITE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: A2-80071-DF BATCH NO: 20036759. IT WAS REPORTED THAT AN ADMINISTRATION SET MODEL WAS LEAKING AT THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408102 ADMIN SET 20 DP, W/ FILTER Y SITE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. A2-80071-DF 20036759 00814371020075

    Patients

    Seq Age Sex Outcome Treatment
    1