BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ PUMP MODULE ADMINISTRATION SET

    MDR report key: 12920922 · Received December 2, 2021

    Report

    Report Number
    9616066-2021-52533
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 12, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203019478
    PMA / PMN Number
    K894842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT OF A FILTER NOT WORKING PROPERLY WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF TUBING DEFECTIVE/ DAMAGED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR THE PROVIDED MODEL AND LOT NUMBER WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BD ALARIS¿ PUMP MODULE ADMINISTRATION SET HAD DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HIWE HAVE HAD SEVERAL TRANSFUSION REACTIONS IN THE LAST 10 DAYS WITH THE CAUSE DETERMINED TO BE CYTOKINES PRESENT IN THE BLOOD PRODUCTS OR RESIDUAL LEUKOCYTES REMAINING AFTER FILTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818583 BD ALARIS¿ PUMP MODULE ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2477-0007 21076392 37613203019478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown