BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11045527 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-75358
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    December 18, 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

    THE CUSTOMER¿S 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 #: 00936330 CASE SUBJECT: NPI 8100 BOLIS AIL LIMIT DURING PM ACCOUNT NAME: MIAMI VETERANS AFFAIRS HEALTH CARE SYSTEM 546 ACCOUNT #: 3860100 ASSET NAME: 8100 PUMP MODULE V9.1.17.7 ASSET LOCATION: CONTACT: (B)(6) CONTACT EMAIL: (B)(6) CONTACT PHONE: (B)(6) CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: BIOMED HAS AN 8100 MODULE GIVING HIM A BOLIS AIL LIMIT DURING PM. SN: (B)(4) FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: FOLLOWED KA 12043 ALARIS INFUSION ALARM BOLUS AIL LIMIT / FLOW BLOCK. THE ISSUE STILL PRESENT. RECOMMENDED TO REPLACE THE AIL SENSOR. BIOMED WILL CONDUCT REPAIR AND CALL BACK IF ANY FURTHER ASSISTANCE IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516419 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1