BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2963133 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00026
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE SECONDARY BACK FLOW INTO THE PRIMARY. THE CUSTOMER STATED THE PRODUCT WOULD NOT BE RETURNED BECAUSE THE TUBING HAD BEEN DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SECONDARY INFUSION OF CHEMOTHERAPY BACK FLOWED INTO THE PRIMARY FLUID. EVENT OCCURRED ON THE IN-PATIENT ONCOLOGY UNIT. THE USER CONFIRMED THE PRIMARY WAS LOWER THAN THE SECONDARY. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33348 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE WEEK OF:| BAXTER SECONDARY SET, MODEL/LOT UNK