BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2193546 · Received July 21, 2011

    Report

    Report Number
    9613251-2011-00160
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATIONS; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED VOLUMES OF OPTIRAY 300 CONTRAST MEDIUM, AT RATES BETWEEN 1.8ML/SEC TO 2.2ML/SEC, VIA A POWER INJECTOR DURING CT SCANS. THE OPTION-LOK MALE ADAPTERS OF THE TUBING SETS WERE CONNECTED TO THE PATIENT'S IV CATHETERS. AFTER UNSPECIFIED LENGTHS OF TIME AFTER THE DELIVERY WAS STARTED, IT WAS REPORTED THE OPTION-LOK MALE ADAPTERS AND THE IV CATHETERS CONNECTIONS BECAME LOOSE. IT WAS REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTION AND BLOOD LEAKED FROM THE CONNECTIONS. THE TUBING SETS WERE EITHER REPLACED OR THE CONNECTIONS WERE TIGHTENED AND THE PROCEDURES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS OF PROCEDURES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LSLF EXT SET W CLV 80FPK FPK HOSPIRA, LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 LIST # SRSFA2225A, MFR TERUMO MEDICAL CORP.| SURSHIELD TEFLON SAFETY IV CATHETERS 22G X 1"