BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10877968 · Received November 20, 2020

    Report

    Report Number
    2016493-2020-45960
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Report Date
    November 5, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 07/20/2017 TO THE PRESENT DATE 11/16/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRE TESTING AND SPECIFICATIONS AND RELEASED BACK TO THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PAUSE BUTTON IS NOT WORKING ON THE KEYPAD. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRE TESTING AND SPECIFICATIONS AND RELEASED BACK TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 07/20/2017 TO THE PRESENT DATE 11/16/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PAUSE BUTTON IS NOT WORKING ON THE KEYPAD. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339355 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1