BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5" BAG SPIKE ADAPTOR W/ SPIROS

    MDR report key: 4407226 · Received September 19, 2014

    Report

    Report Number
    2025816-2014-00111
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATIONS: THE RETURNED 20123-01 5" BAG SPIKE ADAPTOR W/ SPIROS WAS PRESSURE LEAK TESTED AT 10 PSI. THE RESULTS RECORDED THE SETS SPIROS CONNECTOR LEAKED THROUGH A CRACK AT THE MALE LUER END. FURTHER ANALYSIS IDENTIFIED A RADIAL CRACK THAT EXTENDED AROUND THE FULL CIRCUMFERENCE OF THE SPIROS BODY JUST BELOW THE BLUE STRAP AT THE MALE LUER END. THE CHARACTERISTICS OF THE CRACK/DAMAGE WERE BRITTLE IN NATURE AND TYPICAL OF ENVIRONMENTAL STRESS CRACKING. ALTHOUGH NOT ALWAYS REPEATABLE PREVIOUS ENGINEERING INVESTIGATIONS OF THESE TYPES OF MATERIAL DAMAGES/STRESS CRACKS HAVE BEEN REPLICATED. THOSE INVESTIGATIONS FOUND THAT WHEN THE PLASTIC COMPONENTRY IS WEAKENED BY CHEMICAL EXPOSURES AND THEN SUBJECTED TO VARIOUS AXIAL AND/OR TORQUE FORCE IT CAN POTENTIALLY RESULT IN THESE TYPES OF CRACKS/DAMAGES. FINDINGS: THE REPORTED 20123-01 LEAKAGE ISSUE WAS CONFIRMED. THE ENGINEERING EVAL IDENTIFIED THE SOURCE OF THE LEAKAGE WAS DUE TO DAMAGES/RADIAL CRACKS ON THE HOUSING OF THE SPIROS CONNECTOR. THE ENGINEERING REPORT DOCUMENTS THE MOST LIKELY CASE TO BE A COMBINATION OF CHEMICAL EXPOSURES AND USAGE/TECHNIQUES THAT EMPLOYED AXIAL/BENDING TORQUE FORCES.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING LEAKAGE INCIDENT WITH USE OF 20123-01 5" BAG SPIKE ADAPTOR W/ SPIROS, VENTED CAP AND UNK HOSP PUMP TUBING SET. THE INFO RECEIVED REPORTS VP-16 TUBING LEAKED AT CONNECTOR (SITE) "...AS RN CONNECTED THE FLUSH BAG TO THE TUBING. REMAINING VP-16 (<5 CC) CAUGHT BY RN WITH GLOVES. CHEMO FELL DOWN GOWN SLEEVE ONTO RN'S SKIN AND LONG SLEEVE SHIRT. BLOOD BEGAN TO RETURN THROUGH TUBING STILL CONNECTED - RN CLAMPING TUBING, DISCONNECTED IT, AND FLUSHED LINE... RN WASHED SITE (L FOREARM) THOROUGHLY ..." FOLLOWING CHEMO EXPOSURE TREATMENT PROTOCOL, CLINICIAN REPORTEDLY EXPERIENCED NO ADVERSE CONSEQUENCES. DEVICE RETURN: ONE (1) USED 20123-01 5" BAG SPIKE ADAPTER W/ SPIROS, ATTACHED TO AN UNK EXT. SET. VISUAL INSPECTION (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE REPORT NOTED THAT DURING DECONTAMINATION FLUSHING, LEAKAGE WAS SEEN ORIGINATING FROM THE MALE END OF THE 20123-01 DEVICE SETS SPIROS CONNECTOR. UPON CLOSER INSPECTION DAMAGES WERE SEEN ON THE BODY OF THE SPIROS CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585403 5" BAG SPIKE ADAPTOR W/ SPIROS 5" BAG SPIKE ADAPTOR W/ SPIROS FPA ICU MEDICAL, INC. 20123-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SYRINGE - NOI| UNK PUMP TUBING SET