BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS MICROBR EXT SET

    MDR report key: 1816331 · Received August 16, 2010

    Report

    Report Number
    9613251-2010-00107
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER 11402 HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K052722. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING DIFFICULT DISCONNECTION. THE T-CONNECTOR ON THE DISTAL END OF THE TUBING SET WAS CONNECTED DIRECTLY TO THE PATIENT'S CENTRAL LINE TO DELIVER UNSPECIFIED MEDICATIONS REPORTEDLY FOR BLOOD SUGAR STABILIZATION, BLOOD PRESSURE, AND SEDATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CLINICIAN ATTEMPTED TO DISCONNECT THE T-CONNECTOR FROM THE PATIENT'S CENTRAL LINE TO DELIVER AN UNSPECIFIED MEDICATION; HOWEVER, WAS NOT SUCCESSFUL. IT WAS REPORTED THE CLINICIAN THEN USED A HEMOSTAT TO DISCONNECT THE T-CONNECTOR FROM THE CENTRAL LINE AND THE T-CONNECTOR CRACKED. THE TUBING SET WAS REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS MICROBR EXT SET UNK FPA HOSPIRA LTD. NA 78096NS

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO BROVIAC CATHETER MANUFACTURED BY C.R. BARD, INC.