BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11633555 · Received April 8, 2021

    Report

    Report Number
    2016493-2021-501980
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Report Date
    March 16, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2822-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO ELECTRICAL FAILURE OF THE LED DISPLAY GRN 7SEG 7.6MM DIP10. THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN REPLACED DIM U4 ON DISPLAY BOARD FOR EPMS - DIM SEGMENTS 8100 (12). THE FAILURE CODE OTHER WAS USED TO TRACK THE ALARIS PUMP SOFTWARE VERSION AS RECEIVED FROM THE CUSTOMER AND THE SOFTWARE VERSION WHEN DEVICE WAS SENT BACK TO THE CUSTOMER. IT DOES NOT REFLECT A DEVICE FAILURE OR REPRESENT ANY RISK TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 06JUN2018. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER ANSWERED "YES" TO THE SURVEY QUESTION " ARE YOU AWARE OF ANY ISSUES WITH DIMMED LED SEGMENTS WHERE NUMBERS WERE NOT CLEARLY DISPLAYED ON LCD?" 12 LARGE VOLUME PUMPS WERE AFFECTED BY MISSING DISPLAY LIGHTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. EVALUATION PENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER ANSWERED "YES" TO THE SURVEY QUESTION " ARE YOU AWARE OF ANY ISSUES WITH DIMMED LED SEGMENTS WHERE NUMBERS WERE NOT CLEARLY DISPLAYED ON LCD?" 12 LARGE VOLUME PUMPS WERE AFFECTED BY MISSING DISPLAY LIGHTS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534621 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1