BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA UNIT

    MDR report key: 11136584 · Received January 7, 2021

    Report

    Report Number
    2016493-2021-03854
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    November 13, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403812002
    PMA / PMN Number
    K032233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 02/22/2012 TO THE PRESENT DATE 1/5/2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 02/22/2012 TO THE PRESENT DATE 1/5/2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30160 ALARIS PCA UNIT PUMP, INFUSION FRN CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown