BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4161089 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00699
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SILICONE SEGMENT BALLOONED DURING A 0.9% NORMAL SALINE INFUSION. THE DEVICE HAD AN OCCLUSION ALARM AND DOOR WAS NOTED TO BE MOVING. THE USER OPENED THE DOOR AND FOUND THE SILICONE SEGMENT BALLOONED AT THE UPPER FITMENT AREA. THE INFUSION STARTED AT 1203 WITH A PROGRAMMED RATE OF 266ML/HOUR TO INFUSE OVER 1 HOUR. A ZOFRAN 2MG, 1ML IV PUSH WAS ADMINISTERED INTO THE SET'S DISTAL SMARTSITE DURING THE INFUSION. THE IV SET WAS NOT CLAMPED ABOVE THE SMARTSITE DURING THE ZOFRAN IV PUSH, BECAUSE THE USER'S PRACTICE IS NOT CLAMP THE WET WHILE DELIVERING MEDICATIONS INTO SETS THAT ARE INFUSING. THE IV SET WAS REMOVED AND A NEW IV SET WAS HUNG. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431038 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2123-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PUMP MODULE: SN UNK| ALARIS PC UNIT: SN UNK