BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP

    MDR report key: 11478146 · Received March 12, 2021

    Report

    Report Number
    2016493-2021-30017
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Report Date
    March 2, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2719-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 LOGIC BD, FRONT COVER, REAR CASE, BARREL CLAMP, TUBE/SLEEVE DRIVE, WIPER SEAL, LATCH MODULE, U4/U5 ON DISPLAY BD, RT IUI AND LOWER HOUSING.PLUNGER GRIPPER RECALL AND DIM SEGMENT DISPLAY RECALL COMPLETED. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO ELECTRICAL FAILURE OF THE PCBA SYRINGE LOGIC. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 16FEB2017. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Additional Manufacturer Narrative · 0

    CORRECTION :E2 , E3 AND G2. ADDITIONAL INFORMATION : H7, H9 , IMDRF ANNEX A AND G CODES FIELDS ARE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE RECEIVED ALARM - ERROR CODES / MESSAGES, CHANNEL ERROR 13-133-149. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE RECEIVED ALARM - ERROR CODES / MESSAGES, CHANNEL ERROR 13-133-149. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE RECEIVED ALARM - ERROR CODES / MESSAGES, CHANNEL ERROR 13-133-149. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371050 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1