BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3133925 · Received May 1, 2013

    Report

    Report Number
    2016493-2013-00212
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    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). DEVICE NOT REC'D, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOG HAVE BEEN REC'D, STILL WAITING FOR THE DATA SET. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A 50ML BAG OF POTASSIUM WAS HUNG AT 0848 AND WITHIN 10 MINUTES THE BAG WAS EMPTY. THE INFUSION SHOULD HAVE LASTED AN HOUR. NO PT HARM OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190968 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT: UNK| FOUR 50ML POTASSIUM BAGS: MFR/MODEL/LOT: UNK