BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 10083636 · Received May 22, 2020

    Report

    Report Number
    9616066-2020-01720
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    April 29, 2020
    Report Date
    May 4, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403221866
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S COMPLAINT OF TUBING SET SEPARATED AND LEAKED WAS CONFIRMED. THE SEPARATION WAS OBSERVED AT THE ENGAGEMENT BETWEEN THE OUTLET SPIGOT OF THE DRIP CHAMBER AND TUBING ON SET RECEIVED. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE CUSTOMER'S REPORT WAS CONFIRMED UPON VISUAL INSPECTION. DIMENSIONAL TESTING MEASURED THE TUBING TO BE WITHIN SPECIFICATION. DEVICE HISTORY RECORD FOR MODEL 10015862 LOT 20035131 SHOWS THAT THE SET WAS MANUFACTURED ON 3 MARCH 2020 WITH A TOTAL OF 11,523 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. THE ROOT CAUSE OF THE TUBING SEPARATION WAS A MANUFACTURING ISSUE FOR INSUFFICIENT SOLVENT BEING APPLIED AT THE AFFECTED ENGAGEMENT DUE TO EQUIPMENT AND/ OR OPERATOR ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBING SET SEPARATED AT THE DRIP CHAMBER AND LEAKED WHILE PRIMING WITH MAGNESIUM SULFATE 6 G (10G/20ML)/150 ML TO INFUSE AT A RATE OF 2 G/HR FOR A DURATION OF 3 HOURS. THERE WAS NO PATIENT INVOLVEMENT SINCE THE SET DID NOT MAKE IT TO THE BEDSIDE.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBING SET SEPARATED AT THE DRIP CHAMBER AND LEAKED WHILE PRIMING WITH MAGNESIUM SULFATE 6 G (10G/20ML)/150 ML TO INFUSE AT A RATE OF 2 G/HR FOR A DURATION OF 3 HOURS. THERE WAS NO PATIENT INVOLVEMENT SINCE THE SET DID NOT MAKE IT TO THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547188 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10015862 20035131 10885403221866

    Patients

    Seq Age Sex Outcome Treatment
    1