BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA

    MDR report key: 10639063 · Received October 6, 2020

    Report

    Report Number
    2016493-2020-18436
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 17, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403812002
    PMA / PMN Number
    K032233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DATE OF MANUFACTURE (B)(4)2012 TO THE PRESENT DATE (B)(4)2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE 2 TIMES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIRS. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    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 DATE OF MANUFACTURE 23MAR2012 TO THE PRESENT DATE 27OCT2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE 2 TIMES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIRS. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099871 ALARIS PCA PUMP, INFUSION FRN CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1