BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11137725 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03187
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    January 31, 2020
    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

    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

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00979462 CASE SUBJECT: NPI ERROR CODE 232.6040 ON 8100 UNIT ACCOUNT NAME: OHIOHEALTH MANSFIELD HOSPITAL ACCOUNT #: 1021989 ASSET NAME: 8015LS PCU DOM V9.33.1.2 A/B/G/N ASSET LOCATION: CONTACT: BEN JOHNSON CONTACT EMAIL: [email protected] CONTACT PHONE: CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: TECH CALLED IN FOR HELP ON 8100 UNIT SERIAL # (B)(4) FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: TECH CALLED IN FOR HLEP ON 8100 UNIT HAS ERROR CODE 232.6040, BEFORE CALL IN TECH SAID HE RAN PM TEST AND A SMALL INFUSE ERROR NEVER CAME BACK UP. EXPLAIN TO TECH THE ERROR HAS TO DO WITH THE DISPLAY FAILURE RATE DISPLAY SAFETY SYSTEM. IF THE ERROR COMES BACK UP THEY WILL NEED TO REPLACE THE DISPLAY MODULE ON THE UNIT. LOCATE BEHIND THE GREY PANEL OF THE FRONT DOOR. TECH THANK ME FOR MY ASSIST. REF:_00D30Y0YR._5000L1QKOKN:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38791 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1