BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6123233 · Received November 22, 2016

    Report

    Report Number
    9616066-2016-01613
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 31, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A BROKEN TUBING SET WAS CONFIRMED. VISUAL INSPECTION REVEALED A SEPARATION BETWEEN THE TUBING AND THE BOTTOM OF THE FILTER. INSUFFICIENT SOLVENT WAS OBSERVED AT THE END OF THE TUBING WHERE THE SEPARATION OCCURRED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SEPARATION. THE SEPARATED TUBING WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE PROBABLE CAUSE OF THE SEPARATION IS INSUFFICIENT SOLVENT APPLICATION DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100ML NDC 0338-0519-58, LOT 10KA9873, EXP 12/2017, INTRALIPID 20%; THERAPY DATE: (B)(6) 2016. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: GTIN/UDI FOR ITEM 10010453, LOT 16097225 IS (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: OMIT HEALTH PROFESSIONAL FROM REPORT SOURCE ON INITIAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE ASSISTING A PATIENT TO SIT UP IN BED, MAKING SURE THE TPN TUBING HAD ENOUGH SLACK, THE NURSE NOTICED BLOOD BACK UP INTO THE PICC LINE. THE LIPID TUBING HAD DISCONNECTED FROM THE LIPID FILTER AND SNAPPED. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771864 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10010453 16097225

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO (B)(4),PICC, TD: (B)(6) 2016