BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18594321 · Received January 29, 2024

    Report

    Report Number
    2016493-2024-11256
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    December 15, 2023
    Report Date
    January 31, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811043
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMDRF ANNEX B CODES AND MANUFACTURER NARRATIVE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER IS NOTING SYRINGE VOLUME DISCREPANCIES WITH NICU ANTIBIOTICS WHILE USING SYRINGE PUMP. THE CUSTOMER IS USING BD 10ML SYRINGES. THE BELOW IS AN EXAMPLE OF GENTAMICIN DRUG. GENTAMICIN¿ 18.92MG IN 9.46ML PER EPIC ORDER. ALARIS READ VOLUMES: 12/12 0849 = 9.07ML. 12/13 0816 = 9.27ML. 12/14 0814 = 9.25ML. 12/15 0808 = 9.27ML. 12/16 0846 = 9.46ML. 12/17 0846 = 9.46ML. 12/18 0847 = 9.14ML. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER IS NOTING SYRINGE VOLUME DISCREPANCIES WITH NICU ANTIBIOTICS WHILE USING SYRINGE PUMP. THE CUSTOMER IS USING BD 10ML SYRINGES. THE BELOW IS AN EXAMPLE OF GENTAMICIN DRUG. GENTAMICIN¿ 18.92MG IN 9.46ML PER EPIC ORDER. ALARIS READ VOLUMES: (B)(6) 0849 = 9.07ML (B)(6) 0816 = 9.27ML (B)(6) 0814 = 9.25ML (B)(6) 0808 = 9.27ML (B)(6) 0846 = 9.46ML (B)(6) 0846 = 9.46ML (B)(6) 0847 = 9.14ML THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533549 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015