BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP

    MDR report key: 10905944 · Received November 25, 2020

    Report

    Report Number
    2016493-2020-48734
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    July 31, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 07/16/2013 TO THE PRESENT DATE 11/16/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE 1 TIME WITHOUT CORRELATION TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIR. 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 THE DEVICE WAS BROKEN (DAMAGE). REPORTEDLY, THEIR 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 07/16/2013 TO THE PRESENT DATE 11/16/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE 1 TIME WITHOUT CORRELATION TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIR. 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 THE DEVICE WAS BROKEN (DAMAGE). REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370414 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown