BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10744828 · Received October 27, 2020

    Report

    Report Number
    2016493-2020-28348
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    August 26, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR. A REVIEW OF THE DEVICE HISTORY RECORD FOR (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 06/27/2019 TO PRESENT DATE 10/15/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8100 PUMP MODULE WAS BROKEN/DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 06/27/2019 TO PRESENT DATE 10/15/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 8100 PUMP MODULE WAS BROKEN/DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209095 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown