BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11152560 · Received January 11, 2021

    Report

    Report Number
    2016493-2021-05656
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Report Date
    February 25, 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. BASED ON THE FILE REVIEW, NO FURTHER ESCALATION IS REQUIRED PER (B)(4) COMPLAINT ESCALATIONS, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. TECHNICAL SUPPORT TROUBLESHOOT WITH THE CUSTOMER OVER THE PHONE AND CONFIRMED AIR-IN-LINE TESTING FAILING DURING PM. TECHNICAL SUPPORT NOTED THAT, USED KA 12043 ALARIS INFUSION ALARM BOLUS AIL LIMIT / FLOW BLOCK WHICH CORRECTED THE ISSUE. BIOMED ENDED CALL. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM 02/28/2016 TO 03/31/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE. TECHNICAL SUPPORT NOTED THAT: USED KA 12043 ALARIS INFUSION ALARM BOLUS AIL LIMIT / FLOW BLOCK WHICH CORRECTED THE ISSUE. 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 IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: (B)(4). (B)(4). PATIENT OR USER INVOLVEMENT: NO, PATIENT OR USER HARM: NO. CALLER HAS AN 8100 MODULE FAILING AIR-IN-LINE DURING PM. SN: (B)(4) USED KA 12043 ALARIS INFUSION ALARM BOLUS AIL LIMIT / FLOW BLOCK WHICH CORRECTED THE ISSUE. BIOMED ENDED CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41852 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1