BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3944156 · Received May 7, 2014

    Report

    Report Number
    9616066-2014-00439
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 20, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKING COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OCCURRED DURING A CHEMO EPOCH INFUSION. TREATMENT PROTOCOL WAS EPOCH ETOPOSIDE, VINCRISTINE, DOXORUBICIN, CYCLOPHOSPHAMIDE, AND PREDNISONE. THE PATIENT AND NURSE FOUND THE WET TUBING AND LINENS. IT IS UNK WHICH DRUG WAS IN USE AND THE EXACT LOCATION OF THE LEAK. THE PATIENT CONTINUED THE CHEMO INFUSION WITH NEW TUBING. THERE WAS NO REPORT OF PATIENT OR STAFF HARM AS A RESULT OF THE LEAK. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274908 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 10010454 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PHASEAL CONNECTOR, MODEL/LOT UNK