BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6194427 · Received December 21, 2016

    Report

    Report Number
    2016493-2016-00956
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 23, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT THAT A SECONDARY INFUSION OF VANCOMYCIN INFUSED FASTER THAN EXPECTED WAS NEITHER CONFIRMED NOR REPLICATED. THE PCU EVENT LOG SHOWS THAT AT 7:37 PM ON (B)(6) 2016, A SECONDARY INFUSION OF VANCOMYCIN 1000MG/250ML WAS PROGRAMMED FOR A RATE OF 250ML/HR AND VTBI OF 250ML, TO INFUSE OVER 1 HOUR. THE DURATION WAS CHANGED TO 2 HOURS, WHICH MADE THE RATE 125ML/HR. JUST OVER THIRTY MINUTES LATER, THE INFUSION WAS PAUSED AND THEN STOPPED AND THE PRIMARY INFUSION WAS STARTED. THERE WERE NO ALARMS PRIOR TO PAUSING THE SECONDARY INFUSION. FUNCTIONAL TESTING FOUND THE PUMP MODULE TO BE DELIVERING FLUID WITHIN SPECIFICATION. THERE WERE NO LEAKS, BACKFLOW, OR OTHER ANOMALIES OBSERVED WITH THE PRIMARY OR SECONDARY SET. THE ROOT CAUSE OF THE SECONDARY INFUSING FASTER THAN EXPECTED WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG, (B)(4), LOT Y211813, EXP MAR 18M SODIUM CHLORIDE INJECTION; 250ML BAXTER BAG, (B)(4), LOT Y209361, EXP FEB 18, SODIUM CHLORIDE INJECTION AND 1G VIAL OF VANCOMYCIN, (B)(4), LOT 2827167, EXP 05/2018 ATTACHED TO A BAG ACCESS; THERAPY DATE (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH RESULTS WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SECONDARY OF VANCOMYCIN 1000MG/250ML NS WHICH WAS PROGRAMMED TO INFUSE AT 250ML/HOUR INFUSED WITHIN 30 MINUTES. THE PATIENT RECEIVED "EXTRA MONITORING" DUE TO A RASH; ALTHOUGH THE PATIENT WAS NOTED TO HAVE A RASH PRIOR TO THE EVENT, IT EXTENDED BEYOND THE ORIGINAL AREA AFTER THE EVENT OCCURRED. THE PHYSICIAN ORDERED BENADRYL 25MG TO BE GIVEN EVERY 6 HOURS WHEN NEEDED, AND THE PATIENT RECEIVED 4 DOSES. A ROUTINE TROUGH LAB WAS DRAWN ON (B)(6) 2016 @ 16:30, RESULTS ARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844603 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 2426-0500,8015,72213N,