BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM CLOSED MALE LUER WITH FEMAILE CAP

    MDR report key: 10237681 · Received July 6, 2020

    Report

    Report Number
    9616066-2020-02092
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 15, 2020
    Manufacturer
    CAREFUSION NORTH CAROLINA
    Product Code
    FPA
    UDI-DI
    10885403235221
    PMA / PMN Number
    K053049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: THE MATERIAL# WAS UPDATED. THE FOLLOWING FIELDS HAVE BEEN CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE TEXIUM CLOSED MALE LUER WITH FEMALE CAP LEAKED DURING A "46 HOUR AMBULATORY INFUSION". B.1. BRAND NAME: TEXIUM CLOSED MALE LUER WITH FEMAILE CAP. D.3. MEDICAL DEVICE MANUFACTURER: CAREFUSION 303, INC. CREEDMOOR, NORTH CAROLINA. D.4. MODEL#: 10012241-0500. D.4. CATALOG#: 10012241-0500. D.4. UDI#: (B)(4). G.5. PMA/510(K) #: K053049. INVESTIGATION: IT WAS REPORTED THAT THE TEXIUM ADAPTOR LEAKED WHILE CONNECTED TO THE PUMP. RECEIVED ONE USED TEXIUM MALE LUER MODEL 10012241-0500 LOT UNKNOWN. ATTACHED TO THE TEXIUM LUER WAS ONE USED CADD EXTENSION SET. ATTACHED TO THE EXTENSION SET WAS ONE CADD CASSETTE. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/ TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES OR EVIDENCE OF DAMAGES WERE OBSERVED DURING INITIAL VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED BY DETACHING THE EXTENSION SET WITH THE TEXIUM LUER STILL CONNECTED AT THE SET¿S MALE LUER. ONE LAB PRIMARY SET SPIKED TO A LAB IV BAG FILLED WITH BLUE DYE WATER WAS ATTACHED TO THE EXTENSION SET¿S FEMALE LUER. ONE 18G CANNULA WAS ATTACHED AT THE END OF THE TEXIUM LUER. THE SET WAS REPRIMED AND NO LEAKS OR ISSUES WERE OBSERVED. THE SETS WERE THEN LOADED INTO A LAB PUMP MODULE FOR A PRIMARY INFUSION. THE INFUSION WAS PROGRAMMED FOR A RATE OF 33.33ML/HR AND VTBI OF 800ML FOR A SPAN OF 24 HOURS. THE INFUSION COMPLETED WITH NO ALARMS, LEAKS, OR ANY ISSUES. THE PRIMARY SET WAS DETACHED AND THE EXTENSION SET WITH THE TEXIUM LUER WERE PRESSURE TESTED WHILE SUBMERGED UNDERWATER (PER DIR # (B)(4) ¿ IV DISPOSABLE LEAK TEST METHOD). AIR PRESSURE WAS INCREMENTALLY INCREASED FROM 5 PSI TO 30 PSI. NO LEAKS OR ANOMALIES WERE OBSERVED THE CONNECTIONS OR FROM THE TEXIUM LUER. EQUIPMENT USED (MEASUREMENT AND TESTING PERFORMED ON 10SEP2020). 8015 ALARIS PCU 1.5, EQ08330, CALIBRATION DUE DATE: 04AUG2021. 8100 ALARIS SYSTEM LVP, EQ08327, CALIBRATION DUE DATE: 16NOV2020. AIR PRESSURE REGULATOR WITH PRESSURE GAUGE, EQ00138, CALIBRATION DUE DATE: 02OCT2020. A DEVICE HISTORY RECORD COULD NOT BE PERFORMED DUE TO NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE WAS NOT IDENTIFIED BECAUSE NO LEAKS OR ANOMALIES WERE OBSERVED OR REPLICATED DURING FUNCTIONAL AND PRESSURE TESTING. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEXIUM CLOSED MALE LUER WITH FEMALE CAP LEAKED DURING A "46 HOUR AMBULATORY INFUSION". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT WAS SENT HOME WITH CADD INFUSION PUMP FOR 46 HOUR AMBULATORY INFUSION. PT CALLED NEXT MORNING AND INFORMED INFUSION CENTER THAT PUMP WAS LEAKING. PT TOLD TO TURN OFF PUMP AND COME INTO INFUSION CENTER ASAP. WHEN PT ARRIVED, PUMP WAS CONFIRMED TO BE LEAKING FROM GREEN BD TEXIUM ADAPTOR. COMPONENTS INCLUDE 250 ML CADD CASSETTE, CADD TUBING EXTENSION, AND A GREEN BD TEXIUM ADAPTOR."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXT W/ANTISIPHON VLV LEAKED FROM THE GREEN BD TEXIUM ADAPTOR DURING A "46 HOUR AMBULATORY INFUSION". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT WAS SENT HOME WITH CADD INFUSION PUMP FOR 46 HOUR AMBULATORY INFUSION. PT CALLED NEXT MORNING AND INFORMED INFUSION CENTER THAT PUMP WAS LEAKING. PT TOLD TO TURN OFF PUMP AND COME INTO INFUSION CENTER ASAP. WHEN PT ARRIVED, PUMP WAS CONFIRMED TO BE LEAKING FROM GREEN BD TEXIUM ADAPTOR. COMPONENTS INCLUDE 250 ML CADD CASSETTE, CADD TUBING EXTENSION, AND A GREEN BD TEXIUM ADAPTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695276 TEXIUM CLOSED MALE LUER WITH FEMAILE CAP INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION NORTH CAROLINA 10012241-0500 UNKNOWN 10885403235221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200604| 20200604