BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN SET 20 DP, W/ FILTER Y SITE

    MDR report key: 10989258 · Received December 10, 2020

    Report

    Report Number
    9616066-2020-20555
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    May 29, 2020
    Report Date
    March 10, 2021
    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: ONE SAMPLE OF THE A2-80071-DF WAS RECEIVED ON DECEMBER 17TH, 2020, IT WAS TESTED AND THE LEAK IN FILTER WAS CONFIRMED AND SINCE IT WAS RELATED TO A SUPPLIER COMPONENT THE INVESTIGATION WAS REQUESTED TO A SUPPLIER FROM THE SUPPLIER QUALITY ENGINEER HECTOR FIGUEROA. CUSTOMER RETURN SAMPLE WAS EVALUATED AND THE LEAK WAS CONFIRMED FROM WELD AREA. THE PART DID GO THROUGH THE WELDING OPERATION AS WELD LINE WAS VISIBLE AROUND THE PART WHILE THE AREA OF LEAK WAS NOT WELDED AT THE TIME OF TESTING. PART BEING 3 YEAR OLD, THERE'S NO WAY TO ADEQUATELY IDENTIFY WHAT COULD HAVE CAUSED THE FILTER TO UN-WELD. DHR REVIEW OF LOT #141009 WAS CONDUCTED AND NO CHANGES/REJECTIONS WERE IDENTIFIED WHICH COULD HAVE CAUSED A WEAKER WELD. ACTUAL ROOT CAUSE FROM THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FROM REVIEWING THE PART, DHR OR MAINTENANCE LOG. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADMIN SET 20 DP, W/ FILTER Y SITE LEAKED FROM THE FILTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED THAT AN ADMINISTRATION SET MODEL A2-80071-DF LOT 18036934 SET WAS LEAKING AT THE FILTER. OPERATOR RN. MEDICATION UNKNOWN. PATIENT INVOLVED. PATIENT WAS NOT HARMED. (B)(6) 2020".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADMIN SET 20 DP, W/ FILTER Y SITE LEAKED FROM THE FILTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED THAT AN ADMINISTRATION SET MODEL A2-80071-DF, LOT 18036934 SET WAS LEAKING AT THE FILTER. OPERATOR RN. MEDICATION UNKNOWN. PATIENT INVOLVED. PATIENT WAS NOT HARMED. (B)(6) 2020".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446982 ADMIN SET 20 DP, W/ FILTER Y SITE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. A2-80071-DF 18036934 00814371020075

    Patients

    Seq Age Sex Outcome Treatment
    1