BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 2943797 · Received January 30, 2013

    Report

    Report Number
    9616066-2013-00037
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CAREFUSION CORP.
    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). UNABLE TO DETERMINE THE CAUSE OF SEDATION BOLUS NOT REACHING THE PATIENT THROUGH THE EXTENSION SET FILTER. CUSTOMER STATES THAT THE SET WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEY BELIEVE THAT SEDATION MEDICATION INFUSING, THROUGH AN EXTENSION SET FILTER, DID NOT REACH THE PATIENT BECAUSE SEVERAL BOLUSES WERE DELIVERED WITHOUT EFFECT. THE PATIENT WAS FEBRILE AND AGITATED WITH A HEART RATE OF 180-200 AND ELEVATED LACTATE. VERSED AND DILAUDID WERE GOING THROUGH ONE FILTER. THE SETS WERE CONNECTED WITH MULTIPLE TRI-PORT EXTENSIONS WHICH WERE ATTACHED TO THE FILTER CONNECTED CLOSEST TO THE PATIENT. THE SEDATION BOLUS VOLUMES WERE 0.2-0.4 MLS. NO OCCLUSION ALARMS WERE NOTED DURING THE INFUSIONS. THE CUSTOMER HAD ORIGINALLY REPORTED THAT THE EFFECTS OF THE SEDATION REACHED THE PATIENT TOO QUICKLY WHEN THE FILTER WAS REMOVED FROM THE LINE, BUT LATER STATED THAT THE FILTER WAS REMOVED FROM THE LINE AND WITHIN 30 MINUTES THE PATIENT'S HEART RATE DECREASED TO 130-140, THE PATIENT WAS AFEBRILE, AND THE LACTATE RETURNED TO BASELINE. THE CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39972 ALARIS EXTENSION SET FPA CAREFUSION CORP. 10011865 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SYRINGE PUMP ADMIN SET: MANUFACTURER UNK| MEDFUSION SYRINGE PUMP: MODEL UNK, LOT UNK| MODEL UNK, LOT UNK