BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3170467 · Received May 24, 2013

    Report

    Report Number
    2016493-2013-00244
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2013. INTERNAL FILE NO: (B)(4). ALL AFFECTED PRODUCT HAS BEEN REQUESTED. THE EVENT LOGS HAVE BEEN RECEIVED. ALTHOUGH REQUESTED, THE DATA SET HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDER INFUSION. THE PATIENT DID NOT RECEIVE THE TOTAL AMOUNT OF THE DRUG ORDERED BY THE PHYSICIAN. RITUXIMAB ORDER WAS FOR 680MG. THE DOSE WAS RECONSTITUTED WITH 272ML OF 0.9% NS FOR A TOTAL BAG VOLUME OF 340 ML. RITUXIMAB INFUSION WAS STARTED AT 25 ML/HOUR AROUND 1025 ON (B)(6) 2013. THE DURATION VARIES WITH THIS MEDICATION BECAUSE THE NURSE TITRATES THE RATE EVERY 30 MINUTES BASED ON WHETHER OR NOT THE PATIENT TOLERATES THE INFUSION. THE RATE FOR THIS INFUSION RANGED FROM 25 ML/HOUR TO 75 ML/HOUR. THE VOLUME TO BE INFUSED COMPLETED AT 1425 FLUID REMAINING IN IV BAG. THE IV BAG WAS SENT TO PHARMACY FOR MEASUREMENT AND 140 MLS REMAINED IN THE BAG. THE CUSTOMER FEELS THE NURSE PROGRAMMED THE DEVICE FOR 272 ML INSTEAD OF 340 ML FOR THE TOTAL VOLUME. CUSTOMER REQUESTS AN EVENT LOG REVIEW FOR USER PROGRAMMING AND VTBI ENTERED. THERE WAS NO PATIENT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231388 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNK| ALARIS PC UNIT: (B)(4)