BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11558903 · Received March 23, 2021

    Report

    Report Number
    2016493-2021-500081
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    February 26, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2939-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY REPLACED MOUNT RUBBER MOTOR DUE TO 242.4030 ERROR, IUI RIGHT SIDE, LVP KEYPAD RECALL COMPLETED. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO MAINTENANCE ISSUE OF THE MOUNT RER MOTOR. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED, WHICH SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 07JAN2019 AND CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. Z-2718-2020 FOR IUI DAMAGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UNKNOWN ISSUE/NEEDS REPAIR. 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

    THE CUSTOMER REPORTED UNKNOWN ISSUE/NEEDS REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450894 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1