BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11137698 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03317
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    April 20, 2020
    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

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. 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 NOT RETURNED FOR SERVICING WHICH NOT 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

    CASE #: 01057972 CASE SUBJECT: NPI 8100 FAILED RATE CALIBRATION ACCOUNT NAME: MERCY HOSPITAL ACCOUNT #: 10001822 ASSET NAME: 8100 PUMP MODULE 9.17.0.22 RCND ASSET LOCATION: CONTACT: TUCHAO VANG CONTACT EMAIL: CONTACT PHONE: (716) 796 3609 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: TUCHAO HAD A LVP8100 FAILED RATE CALIBRATION. LVP SN (B)(4). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: I REVIEWED THE TEST SET UP WITH TUCHAO AND FOUND OUT THE RATE CALIBRATION SET (8100-RCS) WAS OVER USED (MORE THAN 60 TIMES). I ADVISED TUCHAO TO REPLACE 8100-RCS. IF NEW 8100-RCS DOES NOT RESOLVE THE PROBLEM, TUCHAO WILL REPLACE BEZEL ASSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38591 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1