BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11509544 · Received March 17, 2021

    Report

    Report Number
    2016493-2021-30185
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Report Date
    February 18, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2822-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF A DIM SEGMENT IS CONFIRMED BASED ON THE FIELD ACTION. MANUFACTURING ISSUE CUSTOMERS RECEIVED NOTIFICATION OF THE FIELD ACTION. DEVICE REPAIR OR RETURNS ARE HANDLED WITHIN THE SCOPE OF THE FIELD ACTION. NO FURTHER INFORMATION WILL BE PROVIDED BY THE CUSTOMERS DUE TO THE FIELD ACTION. CUSTOMER RECEIVED FIELD ACTION NOTIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 15895472 (14) 8100 LVP DIM SEGMENT WERE REPLACED BECAUSE OF DEFECTIVE DISPLAY BOARD. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405117 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1