BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 2943979 · Received January 30, 2013

    Report

    Report Number
    9616066-2013-00041
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET 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 STATED THAT THEY BELIEVE THAT SEDATION MEDICATION INFUSING THROUGH AN EXTENSION SET FILTER DID NOT REACH THE PT BECAUSE SEVERAL BOLUSES WERE DELIVERED WITHOUT EFFECT. THE PT WAS FEBRILE, AGITATED AND TACHYCARDIC WITH AN ELEVATED LACTATE. VERSED AND DILAUDID (BOLUS VOLUMES 0.2-0.4 MLS) WERE GOING THROUGH ONE FILTER. THE SET WAS CONNECTED WITH MULTIPLE TRI-PORT EXTENSIONS WHICH WERE ATTACHED TO THE FILTER CONNECTED CLOSEST TO THE PT. NO OCCLUSION ALARMS WERE NOTED DURING THE INFUSIONS. THE CUSTOMER HAD ORIGINALLY REPORTED THAT WHEN THE FILTER WAS REMOVED FROM THE LINE, THE EFFECTS OF THE SEDATION REACHED THE PT TOO QUICKLY, BUT LATER STATED THAT AFTER REMOVAL OF THE FILTER THE PT RETURNED TO BASELINE. THE CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41181 ALARIS EXTENSION SET FPA CAREFUSION CORPORATION 10011865 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MEDFUSION SYRINGE PUMP, MODEL/SN UNK| SYRINGE PUMP ADMIN SET, MFR/MODEL/LOT UNK