BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3222018 · Received July 3, 2013

    Report

    Report Number
    2016493-2013-00301
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 5, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AT 10:53 AM, NURSE PROGRAMMED ZOSYN FOR A 4 HOUR INFUSION. THE PUMP ALARMED AT 11:20 AM AND THE ZOSYN WAS EMPTY. THE HOSPITAL HAS TWO SELECTIONS FOR ZOSYN: RAPID AND EXTENDED. THE NURSE THOUGHT SHE PICKED THE EXTENDED ONE. THE ZOSYN WAS 50 MLS AND WAS SET-UP AS A SECONDARY. THE TUBING WS DISCARDED. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303745 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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