BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11672692 · Received April 15, 2021

    Report

    Report Number
    2016493-2021-502590
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    November 18, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE THAT THE FAMILY MEDICINE DEPARTMENT ENCOUNTERED A FEW DEVICES THAT WERE MISSING THE BARCODE USED FOR SCANNING PURPOSES COULD NOT BE CONFIRMED AS NO PRODUCT WERE RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT OF THAT THE FAMILY MEDICINE DEPARTMENT ENCOUNTERED A FEW DEVICES THAT WERE MISSING THE BARCODE USED FOR SCANNING PURPOSES WAS NOT DETERMINED BECAUSE NO PRODUCT OR DEVICE LOGS WERE RETURNED. NO DEVICE HISTORY SEARCH WAS PERFORMED SINCE NO SOURCE DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. A REVIEW OF THE (B)(6) 2021 COMPLAINT REVIEW BOARD (CRB) DID NOT FIND AN INCREASING TREND FOR THE REPORTED ISSUE OF "DEVICES WITHOUT BARCODE¿ BASED ON THE CRB REVIEW AND THE LIMITED INFORMATION PROVIDED NO FURTHER INVESTIGATION ACTIONS WILL BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FAMILY MEDICINE DEPARTMENT ENCOUNTERED A FEW DEVICES THAT WERE MISSING THE BARCODE USED FOR SCANNING PURPOSES. THERE WAS NO REPORTED PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    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. NO DEVICE WILL BE RETURNED PER CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FAMILY MEDICINE DEPARTMENT ENCOUNTERED A FEW DEVICES THAT WERE MISSING THE BARCODE USED FOR SCANNING PURPOSES. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572604 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1