BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 3122543 · Received May 16, 2013

    Report

    Report Number
    9616066-2013-00363
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SET LEAKED FROM A CRACK AT THE PROXIMAL END WHERE IT WAS CONNECTED TO A MICROCLAVE. NORMAL SALINE WAS INFUSING AT KVO RATE OF 0.2CC - 0.5CC/HOUR. THE PICC LINE ON THIS TUBING BECAME OCCLUDED AND NEEDED AN ALTEPLASE INFUSION WHICH SUCCESSFULLY CLEARED THE OCCLUSION. THERE WAS NO REPORT OF PATIENT HARM. ALTHOUGH REQUESTED NO FURTHER PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216934 ALARIS EXTENSION SET FPA CAREFUSION CORPORATION 10010570 12125971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MANUFACTURERS, MODELS AND LOT NUMBERS UNKNOWN| PICC LINE| MICROCLAVE CONNECTOR