BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10954629 · Received December 5, 2020

    Report

    Report Number
    2016493-2020-57646
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Report Date
    November 12, 2020
    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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE OF A DIM SEGMENT IS CONFIRMED BASED ON THE FIELD ACTION. NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA 1143616 WAS OPENED TO ADDRESS THIS ISSUE. THE DEVICE IS USED FOR TREATMENT PURPOSES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 LVP DEVICES HAD DIM SEGMENTS AND HAD TO BE REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 LVP DEVICES HAD DIM SEGMENTS AND HAD TO BE REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418750 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1