BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10829126 · Received November 12, 2020

    Report

    Report Number
    2016493-2020-37413
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Report Date
    June 5, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DAMAGED UPPER SENSOR. BROKEN RIGHT IUI. BROKEN LEFT IUI. (B)(6) 2018 12:36:35 (B)(6). PO FOR $230 APPROVED BY FERNANDO TREJO, 562-803-1877, [email protected]. SHIPPING & BILLING ADDRESSES CONFIRMED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. (B)(6) 2018 14:23:05 (B)(6). (B)(4).

    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 QUALITY NOTIFICATION #: (B)(4) WAS OPENED FOR THE DEVICE WITH CORRELATION TO THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE AND PRODUCT WAS RETURNED FOR THE 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 THAT 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296694 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1