BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16917823 · Received May 12, 2023

    Report

    Report Number
    2016493-2023-161560
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 19, 2023
    Report Date
    July 17, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-161560 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-161464, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED WITH A INCORRECT "DESCRIBE EVENT OR PROBLEM" AND "IMDRF ANNEX E" AND "IMDRF ANNEX F". THE PATIENT EVENT INCORRECTED RECORDED IN THIS REPORT WAS SUBMITTED UNDER MANUFACTURING REPORT NUMBER: 2016493-2023-161464. OMIT: AGE AT TIME OF EVENT, AGE UNIT, DATE OF BIRTH, SEX, E2321 - LOW BLOOD PRESSURE/ HYPOTENSION, E0703 - APNEA, F2301 - ADDITIONAL DEVICE REQUIRED, F2303 - MEDICATION REQUIRED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE AN UNSPECIFIED NUMBER OF PUMP MODULE LATCH SCREWS BACKED OUT. THIS WAS A GENERAL COMPLAINT AND NO SPECIFIC DETAILS WERE GIVEN AND NO PATIENT INVOLVEMENT OR IMPACT WAS INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE AN UNSPECIFIED NUMBER OF PUMP MODULE LATCH SCREWS BACKED OUT. THIS WAS A GENERAL COMPLAINT AND NO SPECIFIC DETAILS WERE GIVEN AND NO PATIENT INVOLVEMENT OR IMPACT WAS INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OVER INFUSION OF PROPOFOL. THE PROPOFOL WAS INTENDED TO INFUSE AT A RATE OF 60ML/HOUR WITH A TOTAL VOLUME TO BE INFUSED OF 70ML. THE PATIENT REPORTEDLY RECEIVED 500MG OF PROPOFOL UNEXPECTEDLY QUICKLY. FOLLOWING THE EVENT, THE PATIENT BECAME APNEIC AND HEMODYNAMICALLY UNSTABLE. THE PATIENT WAS INTUBATED WITH LARYNGEAL MASK AIRWAYS AND GIVEN EPHEDRINE AND PHENYLEPHRINE. IT WAS NOTED THE PUMP MODULE LATCH SCREW WAS PARTIALLY BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662483 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male