BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4606373 · Received March 12, 2015

    Report

    Report Number
    2016493-2015-00135
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    January 21, 2015
    Report Date
    February 16, 2015
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT REQUIRED DEXTROSE 10% TO TREAT HYPOGLYCEMIA, AND BLOOD SUGAR CHECKS EVERY 30 MINUTES BECAUSE 70 CC OF INSULIN INFUSED OVER 15 MINUTES WHEN IT HAD BEEN INTENDED TO INFUSE AT 5 CC/H. THE CONCENTRATION OF THE INSULIN WAS NOT PROVIDED AND NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169693 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention THERAPY DATE:| ALARIS PC UNIT, SN (B)(4)| ALARIS PRIMARY TUBING, MODEL/LOT# UNK