BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10695453 · Received October 19, 2020

    Report

    Report Number
    2016493-2020-23919
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Report Date
    March 8, 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

    BROKEN DOOR, DOOR ASSEMBLY- HINGE DAMAGE. CASE REAR- DAMAGED/CRACKED. AIL SENSOR ASSEMBLY- CRACKED HOUSING. IUI- CORROSION. THERE WAS NO PATIENT INVOLVEMENT. 03/08/2018 11:13:57 (B)(6). PO FOR $230 APPROVED BY (B)(6). SHIPPING & BILLING ADDRESSES CONFIRMED. 03/16/2018 08:17:34 (B)(6). EST - MNR TO MJR. 03/23/2018 07:21:16 (B)(6). UPDATED FROM MNR TO MJR FOR THE MAJOR REPAIR NEEDED PER LEO FLOR, SERVICE TECH. REPAIR APPROVED BY (B)(6) FOR $365. NO CHANGE TO THE PO#. 03/27/2018 11:30:35 (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 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
    1161712 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1