BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10675670 · Received October 13, 2020

    Report

    Report Number
    2016493-2020-22081
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    September 28, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H3, H6 (METHOD, RESULTS, CONCLUSION), AND H11. ADDITIONAL INFORMATION: G7, H2 AND H10 (INVESTIGATION RESULTS). 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 (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 06/23/2005 TO PRESENT DATE 10/22/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE 06/23/2005 WITHOUT CORRELATION TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIR. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN ISSUE WITH THE DEVICE AIL SENSORS OCCURRED. 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 AN UNKNOWN ISSUE WITH THE DEVICE AIL SENSORS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132997 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1