BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 2894011 · Received December 19, 2012

    Report

    Report Number
    2016493-2012-00527
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 23, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND LOG REVIEW IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A NURSE WAS WALKING PAST THE ROOM AND HEARD THE DEVICE ALARMING (UNSPECIFIED ALARM) AND FOUND THE TUBING TO BE BURNING. A BAG OF NORMAL SALINE WAS HUNG AND THE BAG HAD A BLACKENED AREA OF SMOKE DAMAGE FORM THE BURNING. THE TUBING WAS NOTED TO BE LAYING ON THE SIDE OF THE PCU, DRAPED OVER IUI. THERE WAS NO MODULE ATTACHED ON THAT SIDE. THE ONLY INFUSION WAS NORMAL SALINE WHICH WAS INFUSING THROUGH A MODULE ON THE OTHER SIDE. THE NURSE IMMEDIATELY UNPLUGGED THE DEVICE FROM THE WALL AND TURNED OFF THE PCU. THE BAG TUBING WERE DISCARDED AND THE PCU WAS SENT TO BIOMED. THERE WAS NO PATIENT IMPACT. CUSTOMER STATED THAT NO FURTHER INFORMATION IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE ADMIN SET: LOT/MODEL: UNK| FLOW REGULATOR EXTENSION SET: MNF, MODEL/LOT#: UNK| ALARIS PUMP MODULE: SN: UNK| NORMAL SALINE BAG: MANUFACTURER, LOT/EXP DATE: UNK