BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11010754 · Received December 15, 2020

    Report

    Report Number
    2016493-2020-68695
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Report Date
    May 9, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BROKEN/DAMAGED CASE FRONT- DAMAGED/CRACKED CASE REAR- DAMAGED/CRACKED DISPLAY BOARD- SEGMENT DIM HANDLE- DAMAGED/CRACKED IUI- CORROSION - (B)(4). COMPONENTS WERE NOT INITIALLY ENTERED. OPERATIONS PORTION OF THE NOTIFICATIONS IS CLOSED OUT AND CANNOT BE REOPENED. BELOW IS A LIST OF THE PARTS REPLACED: TC10008828 TC10003937 TC10006400 TC10008586 147737-002 147882-002 142794-000 (X2) TC10007985 P00000021 148013-000 11644514 (24 INCHES) TC10003216 12280673 145270-000 12280674 TC10007599.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479766 8110 ALARIS SYRINGE PUMP PUMP,INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1