BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10947308 · Received December 4, 2020

    Report

    Report Number
    2016493-2020-54365
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    January 25, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    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 01/25/2019 05:49:41 THONG TRANG (TTRANG) ESTIMATE MNR WAITING FOR APPROVAL. 02/06/2019 10:27:54 JESSICA GALANG (JGALANG) UPDATED FROM PRW TO MNR FOR THE MINOR REPAIR NEEDED PER THONG TRANG, SERVICE TECH. REPAIR APPROVED BY RICK MCGAHAN AT [email protected] FOR $230. NEW PO# IS 841010-19035. 02/11/2019 14:21:14 THONG TRANG (TTRANG) REPLACED DISPLAY BOARD, PLATEN ASSEMBLY, BEZEL ASSEMBLY. 02/12/2019 07:32:18 ANNETTE A MENDEZ (AMENDEZ) 100190171182000454290048098288136

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413001 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1