BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SE PRIMARY INFUSION SET

    MDR report key: 4072119 · Received August 27, 2014

    Report

    Report Number
    9616066-2014-00913
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 29, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); SAMPLE INVOLVED IN THE EVENT WILL NOT BE RETURNED AS IT WAS NOT AVAILABLE. NO FAILURE INVESTIGATION COULD BE PERFORMED. DURING A SITE VISIT BY CAREFUSION REPRESENTATIVES, THE CUSTOMER INDICATED THAT THE RECENT INCREASE IN THE REPORTED DRUG REACTIONS APPEARS TO COINCIDE WITH SUMMER ENVIRONMENTAL TEMPERATURES. RECONSTITUTED DRUGS WERE NOT BEING STORED IN THE REFRIGERATOR DURING THIS TIME AS INDICATED IN THE DIRECTION FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY 2 MONTHS AFTER CHANGING FROM HOSPIRA SETS TO CAREFUSION, THEY HAVE NOTICED AN INCREASE IN DOCETAXEL REACTIONS WITH THEIR PATIENTS. THE REPORT SUGGESTS THAT 20 TO 40 MINUTES INTO THE INFUSION THE PATIENT COMPLAINED OF DIFFICULTY BREATHING, SHORTNESS OF BREATH, GENERALLY NOT FEELING WELL AND LOW BLOOD PRESSURE. SANOFI (MANUFACTURER OF DOCETAXEL) HAS ADVISED THE CUSTOMER THAT THEY HAVE NOT SEEN ANY DEVIATIONS OR ANOMALIES IN THEIR MANUFACTURING RECORDS AND HAVE RECEIVED NO OTHER REPORTS OF AN INCREASE IN PATIENT REACTIONS TO DOCETAXEL. THE HOSPITAL HAS ALSO CONFIRMED THAT THERE HAVE BEEN NO OTHER CHANGES IN THEIR CLINICAL PRACTICE WITHIN THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519694 ALARIS SE PRIMARY INFUSION SET IV INFUSION SET FPA CAREFUSION CORPORATION 72923E-006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ALARIS SE PUMP - SERIAL NUMBER UNKNOWN, THERAPY| DATE: