BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2962010 · Received January 23, 2013

    Report

    Report Number
    2016493-2013-00076
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 3, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS HAVE BEEN RECEIVED AND ALTHOUGH REQUESTED, RECEIPT OF THE DATASET IS STILL PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 2400 ML OF TPN WAS STARTED AT 8:04 PM ON (B)(6) AND WAS EXPECTED TO LAST 24 HOURS BUT THE NEXT MORNING AT 9:26 AM THE BAG WAS EMPTY. THE TPN WAS PROGRAMMED AS A PRIMARY. IT IS BELIEVED THAT GUARDRAILS AND CRITICAL CARE PROFILE WERE USED. ADDITIONAL CHANNELS WERE RUNNING BUT SPECIFICS FOR THESE INFUSIONS ARE UNKNOWN. THE BIOMED TESTED THE DEVICE AND NO ISSUES WERE IDENTIFIED. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32245 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULES: SN UNK| ALARIS PUMP MODULE ADMINISTRATION SETS:| MODEL #UNK, LOT #UNK