BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 10774242 · Received November 2, 2020

    Report

    Report Number
    2016493-2020-31101
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Report Date
    September 21, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE 09/19/2005 TO THE PRESENT DATE 10/20/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE TWICE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIRS. THIS SHALL BE REVIEWED AS PART OF PART USAGE TRENDING IN COMPLAINT REVIEW BOARD. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD BEEN BROKEN/DAMAGED. NO PATIENT INVOLVEMENT WAS REPORTED.

    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. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF MANUFACTURE 09/19/2005 TO THE PRESENT DATE 10/20/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE TWICE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIRS. THIS SHALL BE REVIEWED AS PART OF PART USAGE TRENDING IN COMPLAINT REVIEW BOARD. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD BEEN BROKEN/DAMAGED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239189 ALARIS SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown