BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2190091 · Received June 29, 2011

    Report

    Report Number
    2016493-2011-00394
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVAL HAS NOT YET BEGUN. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A NURSE HUNG A DOBUTAMINE INFUSION AND 13 HOURS LATER THE BAG WAS COMPLETELY FULL. WHEN THE PUMP MODULE DOOR WAS OPENED THE TUBING WAS FLATTENED BETWEEN THE UPPER AND LOWER PRESSURE SENSORS (BETWEEN THE FINGERS). CUSTOMER IS REQUESTING A DEVICE EVENT LOG REVIEW. TO CHECK PROGRAMMING AND SEE IF THERE WERE ALARMS THAT MIGHT HAVE OCCURRED. NO PT HARM OR MEDICAL INTERVENTION REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, S/N (B)(4)