BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2576761 · Received May 9, 2012

    Report

    Report Number
    2016493-2012-00225
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    February 1, 2012
    Report Date
    April 19, 2012
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR¿S REPORT DATE: 05/16/2012. (B)(4). THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND LOG REVIEW IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS RECEIVING CYTOXAN OVER A 4 DAY PERIOD. FOUR BAGS OF CYTOXAN 545 MG/250MLS WERE HUNG TO EACH INFUSE OVER 24 HOURS. THE 1ST BAG WAS HUNG ON (B)(6) 2012 AT 1840, THE 2ND BAG WAS HUNG ON (B)(6) 2012 AT 1854, THE 3RD BAG WAS HUNG ON (B)(6) 2012 AT 1734 AND THE 4TH BAG WAS HUNG ON (B)(6) 2012 AT 1545. IT WAS REPORTED THAT ONE OF THE BAGS ENDED 1.5 HOURS EARLY (NO SPECIFICS ON WHICH BAG WAS INVOLVED). BIOMED TESTED THE PUMP AND REPORTED THAT IT TESTED WITHIN SPECS. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADD¿L EVENT OR PT INFO IS AVAILABLE. MFR¿S REPORT NUMBER: 2016493-2012-00225. MFR¿S REPORT DATE: 05/16/2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL/LOT # UNK| ALARIS PC UNIT: SN (B)(4)| THERAPY DATES BETWEEN: (B)(6) 2012| THERAPY DATES BETWEEN (B)(6) 2012