BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16917786 · Received May 12, 2023

    Report

    Report Number
    2016493-2023-161558
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    February 21, 2023
    Report Date
    June 30, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION : IMDRF ANNEX A CODE.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE PCU EVENT LOG INDICATED THE DISCONNECTION OCCURRED BETWEEN THE PCU AND PUMP MODULE S/N (B)(6). INSPECTION OF THE PCU¿S MALE IUI CONNECTORS FOUND DRIED FLUID ON THE CONTACTS. THE IUI CONNECTORS FROM PUMP MODULE S/N (B)(6) COULD NOT BE INSPECTED. ALTHOUGH REQUESTED, THE PUMP MODULE WAS NOT RETURNED FOR THIS INVESTIGATION. THIS REPORT IS SUBMITTED FOR PUMP MODULE S/N (B)(6). PLEASE REFER TO MFR REPORT # 2016493-2023-132400 FOR THE REPORT ON THE PCU INVOLVED IN THIS EVENT. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3: DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICES TURNED OFF UNEXPECTEDLY DURING A NOREPINEPHRINE INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICES TURNED OFF UNEXPECTEDLY DURING A NOREPINEPHRINE INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651697 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown