BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3063354 · Received March 27, 2013

    Report

    Report Number
    2016493-2013-00172
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE DEVICES HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A BIOMED REPORTED THAT AN INSULIN INFUSION WAS ADMINISTERED IN 90 MIN HOWEVER THE INTENDED PROGRAMMING WAS FOR 8 HOURS. THE NURSE HAD REPORTED TO THE BIOMED THAT THE DEVICE HAD INFUSED TOO FAST. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124957 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| MODEL/LOT UNK| ALARIS PUMP MODULE ADMINISTRATION SET: