BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP MODULE

    MDR report key: 11094988 · Received December 30, 2020

    Report

    Report Number
    2016493-2020-85886
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    November 12, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAS COSMETIC DAMAGE ON THE FRONT AND REAR CASE. THE DAMAGE CONTAINS GAB. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT. CHARGES APPLY. NPI. COSMETIC DAMAGE, FRONT AND REAR CASE CONTAINS GAB.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS COSMETIC DAMAGE ON THE FRONT AND REAR CASE. THE DAMAGE CONTAINS GAB. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT. CHARGES APPLY. NPI. COSMETIC DAMAGE, FRONT AND REAR CASE CONTAINS GAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559876 ALARIS SYRINGE PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1