BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10669148 · Received October 13, 2020

    Report

    Report Number
    2016493-2020-20163
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    February 22, 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

    PHYSICAL DAMAGE. BEZEL ASSEMBLY- LOWER HINGE CRACK. CASE REAR- CRACKED. DOOR ASSEMBLY- HINGE DAMAGE. IUI- CORROSION. DOOR LATCH ASSEMBLY- SEAR CRACKED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4). SHIPPING & BILLING ADDRESS CONFIRMED. CUSTOMER CANNOT APPROVE LEVEL 2. PLEASE CONTACT CUSTOMER IF ADDITIONAL CHARGES APPLY. (B)(4). EST - MNR TO MJR. (B)(4). UPDATED FROM MNR TO MJR FOR THE MAJOR REPAIR NEEDED PER (B)(4), SERVICE TECH. REPAIR APPROVED BY (B)(4). NO CHANGE TO THE PO#. (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 TRACKWISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS PREVIOUSLY RETURNED FOR SERVICE. 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 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. CAPA REFERENCE:(B)(4). 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
    1139546 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1