BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3060008 · Received March 19, 2013

    Report

    Report Number
    9616066-2013-00187
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS NOT SAVED. THE CUSTOMER COMPLAINT OF LEAKING CONNECTION COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    PHARMACIST REPORTED CHEMO LEAKED BETWEEN CAREFUSION SET AND TEVADAPTOR SYRINGE ADAPTOR CLOSED SYSTEM DEVICE. CANCER PT RECEIVING PACLITAXEL OVER 3 HOURS, PACLITAXEL ADDED TO 500 ML BAG NS. LEAKING CONNECTION OBSERVED, RN STOPPED THE LEAK, CLEANED UP THE SPILL, AND NO HARM TO PT OR STAFF OCCURRED. NO OTHER ISSUES REPORTED WITH THE INFUSION. NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT THE USER DID NOT PROVIDE ANY ADDITIONAL PT/EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113194 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 11130148 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN, UNK| TEVADAPTOR LUER LOCK ADAPTOR: MODEL/LOT UNK| B BRAWN 500 ML XL BAG: NORMAL SALINE| MEDIPORT: MANUFACTURER/MODE/LOT UNK| TEVADAPTOR SYRINGE ADAPTOR: PART #(B)(4), LOT UNK