BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10731278 · Received October 23, 2020

    Report

    Report Number
    2016493-2020-20205
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Report Date
    October 7, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2822-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO DEVICE HISTORY OR QN SEARCH WAS PERFORMED SINCE NO SOURCE DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. THE DEVICE IS USED FOR TREATMENT PURPOSES. NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD DIMMED LED SEGMENTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. ALTHOUGH REQUESTED, PATIENT DEMOGRAPHICS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD DIMMED LED SEGMENTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190283 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1