BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17103747 · Received June 12, 2023

    Report

    Report Number
    2016493-2023-180482
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 17, 2023
    Report Date
    July 27, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. CORRECTION : DESCRIBE EVENT OR PROBLEM. ADDITIONAL INFORMATION : AGE AT TIME OF EVENT, AGE UNIT, DATE OF BIRTH, SEX, DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, CONCOMITANT MED PROD DATA, FDA NOTIFIED?, REPORT SOURCE, REPORT SOURCE OTHER, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY, IMDRF ANNEX A, G B, C 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. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.

    Additional Manufacturer Narrative · 0

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. 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 : NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED AN OVER INFUSION OF A MAGNESIUM (2 GRAMS IN 50ML) SECONDARY INFUSION. THE PRIMARY INFUSION WAS LACTATED RINGERS SOLUTION. THE INTENDED RATE OF MAGNESIUM WAS 25ML/HOUR WITH A DURATION OF 2 HOURS AND VOLUME TO BE INFUSED OF 50ML. AFTER 7 MINUTES, THE CLINICIAN NOTED THAT THE BAG WAS EMPTY AND THE DRIP CHAMBER WAS NOT DRIPPING. THE CLINICIAN PAUSED THE PUMP AND IT WAS NOTED THAT THE DRIP CHAMBER ON THE PRIMARY LINE IS COMPLETELY FULL. THE PATIENT COMPLAINED OF PAIN AT THE IV INSERTION SITE. THE PRIMARY BAG WAS NOTED TO HAVE MORE FLUID THAN WAS EXPECTED. THE PATIENT WAS ASSESSED AND ALL VITALS WERE STABLE. ANOTHER BAG OF FLUID WAS HUNG AND IT WAS NOTED THAT FLUID WAS BUBBLING INTO THE FLUID CHAMBER OF THE PRIMARY INFUSION LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES, "THE NURSE WENT IN FOR THE FIRST PASS OF THE DAY, HAD A PRIMARY LINE RUNNING AT 25ML/HR, ADDED A SECONDARY BAG TO ANOTHER PUMP WITH 2 GRAMS OF MAGNESIUM IN A 50ML BAG. THE BAG IS SUPPOSED TO BE RUNNING AT 25ML/HR FOR TWO HOURS. THE DOCTOR CAME IN, AND ABOUT SEVEN MINUTES LATER THE NURSE LOOKS OVER AND THE SECOND BAG IS EMPTY AND THE DRIP CHAMBER IS NOT DRIPPING. AFTER NOTICING THIS, SHE PAUSED THE PUMP. AT THIS POINT THE PATIENT IS NOT COMPLAINING OF ANY PAIN OR BURNING SENSATIONS THAT WOULD NORMALLY OCCUR WHEN TOO MUCH MAGNESIUM IS INFUSED AT ONCE. SHE NOTICES THAT THE DRIP CHAMBER ON THE PRIMARY LINE IS NOW COMPLETELY FULL, SHE THINKS THAT THE MAGNESIUM RAN UP THE PRIMARY LINE. THEY PULL THE PUMP SET UP OUT OF THE ROOM AND TEST IT."

    Description of Event or Problem · 0

    IT WAS REPORTED AN OVER INFUSION OF A MAGNESIUM (2 GRAMS IN 50ML) SECONDARY INFUSION. THE PRIMARY INFUSION WAS LACTATED RINGERS SOLUTION. THE INTENDED RATE OF MAGNESIUM WAS 25ML/HOUR WITH A DURATION OF 2 HOURS AND VOLUME TO BE INFUSED OF 50ML. AFTER 7 MINUTES, THE CLINICIAN NOTED THAT THE BAG WAS EMPTY AND THE DRIP CHAMBER WAS NOT DRIPPING. THE CLINICIAN PAUSED THE PUMP AND IT WAS NOTED THAT THE DRIP CHAMBER ON THE PRIMARY LINE IS COMPLETELY FULL. THE PATIENT COMPLAINED OF PAIN AT THE IV INSERTION SITE. THE PRIMARY BAG WAS NOTED TO HAVE MORE FLUID THAN WAS EXPECTED. THE PATIENT WAS ASSESSED AND ALL VITALS WERE STABLE. ANOTHER BAG OF FLUID WAS HUNG AND IT WAS NOTED THAT FLUID WAS BUBBLING INTO THE FLUID CHAMBER OF THE PRIMARY INFUSION LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269849 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male 8015