BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10988315 · Received December 10, 2020

    Report

    Report Number
    2016493-2020-64314
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Report Date
    November 19, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2718-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SEE INVESTIGATION CONCLUSION BELOW. MANUFACTURING ISSUE: 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. H3 OTHER TEXT : NO PRODUCT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ISSUES WITH DIMMED LED SEGMENTS WHERE NUMBERS WERE NOT CLEARLY DISPLAYED ON LCD. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 THERE WERE ISSUES WITH DIMMED LED SEGMENTS WHERE NUMBERS WERE NOT CLEARLY DISPLAYED ON LCD. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446644 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1