BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE TRIFUSE EXT. SET

    MDR report key: 5879400 · Received August 16, 2016

    Report

    Report Number
    2025816-2016-00084
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Date of Event
    July 19, 2016
    Report Date
    August 26, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K941190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO (2) YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/SIMILAR PROBLEM DID NOT RECORD ANY ADDITIONAL REPORTS.

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A TWO (2) YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/SIMILAR PROBLEM DID NOT RECORD ANY ADDITIONAL REPORTS. RECEIVING INSPECTION:8/2/2016 - RECEIVED THE FOLLOWING DEVICES: (17) NEW B1307, 4" SMALLBORE TRIFUSE EXT. SET W/CLAMPS AND ROTATING LUER LOT# 3191119, (4) NEW B1307, 4" SMALLBORE TRIFUSE EXT. SET W/CLAMPS AND ROTATING LUER LOT# 3231366, (105) NEW B1307, 4" SMALLBORE TRIFUSE EXT. SET W/CLAMPS AND ROTATING LUER LOT# 3191120, (19) NEW B1307, 4" SMALLBORE TRIFUSE EXT. SET W/CLAMPS AND ROTATING LUER LOT# 3183024, (1) NEW SMITHS MEDICAL 20IN EXT SET REF# MX450FL LOT# 2582710. (3) NEW BD LEVER LOCK CANNULA REF 303370. FUNCTIONAL TESTING: SEVERAL LOTS OF NEW B1307 TRIFUSE EXTENSION SET ASSEMBLIES WERE RETURNED FOR INVESTIGATION. EACH OF THE ASSEMBLIES FROM EACH OF THE LOTS WERE PRESSURE LEAK TESTED. NO LEAKAGE WAS OBSERVED IN ANY OF THE RETURNED SAMPLES. EACH OF THE RETURNED NEW B1307 TRIFUSE EXTENSION SET ASSEMBLIES FROM EACH LOT WERE TESTED FOR COMPONENT BOND STRENGTH. ALL BONDS JOINTS FROM EACH OF THE B1307 TRIFUSE EXTENSION SET LOTS MET BOND STRENGTH EXPECTATIONS. ANALYSIS SUMMARY: THE COMPLAINT OF B1307 TRIFUSE EXTENSION SET DISCONNECTING (BREAKING/LEAKING) WAS UNABLE TO BE CONFIRMED OR REPLICATED. EACH OF THE RETURNED B1307 TRIFUSE EXTENSION SET ASSEMBLIES WERE PRESSURE LEAK TESTED AND BOND STRENGTH TESTED. EACH OF THE ASSEMBLIES MET PRODUCT PERFORMANCE EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE B1307, 4" SMALLBORE TRIFUSE EXT. SET W/CLAMPS AND ROTATING LUER, LOT NUMBER UNKNOWN. REPORT STATES, "UPON BEGINNING OF SHIFT, PATIENT WAS DISCOVERED TO HAVE IV TUBING DISCONNECTED FROM PICC ACCESS PORT. YELLOW ALLIGATOR CLAMP WAS NOT "CLICKED" INTO PLACE AT ACCESS PORT. TPN AND LIPIDS WERE INFUSING INTO BEDDING WHICH WAS SATURATED. PATIENT WAS RECEIVING INTRALIPID 20%. PATIENT'S BLOOD SUGAR WAS CHECKED AND FOUND TO BE 57. TUBING WAS REPLACED AND NEW FLUIDS WERE HUNG. SECOND BLOOD GLUCOSE WAS CHECKED ONE HOUR LATER AND WAS 120. NO FURTHER INTERVENTIONS NEEDED. NO HARM TO PATIENT. PATIENT WAS A MALE, BORN (B)(6)."

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE B1307, 4" SMALLBORE TRIFUSE EXT. SET W/CLAMPS AND ROTATING LUER, LOT # UNKNOWN. REPORT STATES, "UPON BEGINNING OF SHIFT, PATIENT WAS DISCOVERED TO HAVE IV TUBING DISCONNECTED FROM PICC ACCESS PORT. YELLOW ALLIGATOR CLAMP WAS NOT "CLICKED" INTO PLACE AT ACCESS PORT. TPN AND LIPIDS WERE INFUSING INTO BEDDING WHICH WAS SATURATED. PATIENT WAS RECEIVING INTRALIPID 20%. PATIENT'S BLOOD SUGAR WAS CHECKED AND FOUND TO BE 57. TUBING WAS REPLACED AND NEW FLUIDS WERE HUNG. SECOND BLOOD GLUCOSE WAS CHECKED ONE HOUR LATER AND WAS 120. NO FURTHER INTERVENTIONS NEEDED. NO HARM TO PATIENT. PATIENT WAS A MALE, BORN (B)(6) 2016."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532862 SMALLBORE TRIFUSE EXT. SET SMALLBORE TRIFUSE EXT. SET FPA ICU MEDICAL, INC. B1307 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO