BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 12008073 · Received June 16, 2021

    Report

    Report Number
    2016493-2021-54301
    Event Type
    Death
    Date Received
    June 16, 2021
    Date of Event
    May 21, 2021
    Report Date
    July 22, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2717-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: G02001 - ANTENNA.

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE COMPLAINT HISTORY FOR THIS SERIALIZED UNIT DID NOT CONFIRM SIMILAR COMPLAINTS, BASED ON THE SAME OR RELATED FAILURE MODE FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE SERVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A SERVICE FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE ON (B)(6) 2021 THE PUMP STOPPED AND THE PATIENT SUBSEQUENTLY DIED THE SAME DAY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE ON (B)(6) 2021 THE PUMP STOPPED AND THE PATIENT SUBSEQUENTLY DIED THE SAME DAY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE ON (B)(6) 2021 THE PUMP STOPPED AND THE PATIENT SUBSEQUENTLY DIED THE SAME DAY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE ON 05/21/2021 THE PUMP STOPPED AND THE PATIENT SUBSEQUENTLY DIED THE SAME DAY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL CENTER. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION OF NOREPINEPHRINE ON (B)(6) 2021 THE PUMP STOPPED AND THE PATIENT SUBSEQUENTLY DIED THE SAME DAY. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910106 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death 8015| 8100| 8100(2)| 8100(2)| 8100(2)