BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3043466 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00168
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    NURSE CALLED TO REPORT THAT A NURSE CONNECTED AN INFUSION TO A PT AND WHEN SHE CLOSED THE DOOR TO PROGRAM THE DEVICE, IT STARTED LEAKING FROM BEHIND THE DOOR. THE LEAK WAS REPORTED TO BE COMING OUT FROM BELOW THE UPPER FITMENT. THE NURSE REPORTED THE LEAK WAS MOSTLY SALINE, WHICH THE PHARMACY HAD PRIMED THE TUBING WITH, BUT MAY HAVE BEEN MIXED WITH METHOTREXATE SINCE THAT IS WHAT WAS IN THE BAG. THE NURSE CALLED FOR A SPILL KIT, PLACED THE CHEMOTHERAPY BACK IN THE BAG FROM PHARMACY, AND THE ROOM WAS CLEANED. THE NURSE HAD TO WAIT UNTIL MORNING TO GET A NEW BAG OF METHOTREXATE SINCE THE CHEMO PHARMACISTS DO NOT WORK AT NIGHT. THE PT'S INFUSION WAS DELAYED. THERE WAS NO REPORT OF PT OR USER 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
    106275 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR ALARIS PC UNIT, SN UNKNOWN| ALARIS PUMP MODULE, SN UNKNOWN