BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER EXT SET-JAPAN ONLYSTD. BORE 12/.7CM W/LUER LOCK

    MDR report key: 1755768 · Received July 14, 2010

    Report

    Report Number
    6000001-2010-01316
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    January 4, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE SAMPLE WAS DISCARDED THEREFORE, NO EVALUATION WILL BE PERFORMED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON 03/09/2010, A (B) (6) PHYSICIAN AND NURSE REPORTED A DEPRESSED LEVEL OF CONSCIOUSNESS THAT OCCURRED ON (B) (6)2010 IN A (B) (6) MALE PATIENT WITH A DIAGNOSIS OF DEMENTIA COINCIDENT WITH USE OF THE INTERLINK I.V. ACCESS SYSTEM DURING INFUSION OF TOTAL PARENTERAL NUTRITION (TPN). FULCALIQ (HIGH CALORIE INFUSION) WAS INFUSING AT 80CC/HOUR. THREE TO FIVE CC OF AIR WAS VISIBLE IN THE COMPUTED AXIAL TOMOGRAPHY (CT) IMAGE. IT WAS FEARED THAT AIR WAS INFUSED INTO A VEIN FROM CONNECTION POINT OF INFUSION SET. THE INFUSION SET IS REPLACED EVERY 3 DAYS. THERE WAS NO EVIDENCE OF LEAK. THE Y ON THE INFUSION SET WAS NOT USED. FROM (B) (6)2009 TO (B) (6)2010, THE INTERLINKS WERE CHANGED EVERY 72HOURS. ON (B) (6)2010, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO OBTAIN SECOND OPINION. THE SECOND OPINION INDICATED, THE AIR WAS POSSIBLY AN IATROGENIC EVENT AND THE AIR CAUSED THE DEPRESSED LEVEL OF CONSCIOUSNESS. ON (B) (6)2010, THE PATIENT WAS RETURNED TO THE HOSPITAL. ON (B) (6)2010, A MEETING BETWEEN THE HOSPITAL AND THE PATIENT'S FAMILY WAS HELD. IN THE MEETING, THE HOSPITAL STAFF INDICATED THE ACTUAL SAMPLE CANNOT BE INVESTIGATED BECAUSE THE SAMPLE HAD BEEN DISCARDED. HOWEVER, THE POSSIBILITY THAT AIR WAS ENTRAPPED FROM THE CONNECTION BETWEEN THE INTERLINK I.V. ACCESS SYSTEM AND THE INFUSION SET REMAINED. THE POSSIBLE CAUSE WAS USER ERROR DUE TO LIMITED SUPERVISION OF HOSPITAL STAFF. THE ACTUAL SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. THE CAUSALITY BETWEEN THE INTERLINK AND THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER EXT SET-JAPAN ONLYSTD. BORE 12/.7CM W/LUER LOCK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R FULCALIQ (HIGH CALORIE INFUSION) WAS INFUSED 80CC/