BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3281431 · Received July 24, 2013

    Report

    Report Number
    9616066-2013-00561
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 24, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    EMAIL RECEIVED FROM CUSTOMER THAT "I HAVE TWO MORE TUBING SETS TO GO BACK." ADD'L EVENT INFO RECEIVED FROM COMPLETED BALLOON SEGMENT QUESTIONAIRE: MEDICATION INFUSING CYTARABINE AT 43 ML/HR INFUSION HAD BEEN RUNNING FOR 16 HOURS AND 20 MINUTES WHEN ISSUE WAS IDENTIFIED; IV SET HAD BEEN IN USE FOR 1 DAY. AN ICU MEDICAL 5" EXTENSION SET (20123-01) AND SPIROS (20130-01) ATTACHED TO THE END OF THE PRIMARY SET. THE PUMP MODULE ALARMED FOR PT-SIDE OCCLUSION. THE PT HAD ORDERS FOR IV PUSH MEDICATIONS AND AN IMAGING PROCEDURE. NARRATIVE: "RN NOTICED PUMP ALARMING. DISCONNECT TUBING AND FLUSHED PICC LINE WITHOUT DIFFICULTY RECONNECTED TUBING AND PUMP STILL ALARMING. OPENED DOOR ON IV PUMP AND NOTICED BALLOONING." NO PT HARM OT MEDICAL INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347266 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PUMP MODULE: SN UNK| ICU MEDICAL 5" EXTENSION SET: MODEL 20123-01,| LOT # UNK| ALARIS PC UNIT: SN UNK| PICC LINE: MFR/MODEL/LOT UNK