BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS CONNECTORS

    MDR report key: 5240746 · Received November 20, 2015

    Report

    Report Number
    2025816-2015-00136
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 26, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION (PRE AND POST DECONTAMINATION) OF THE FOUR RETURNED USED SPIROS CONNECTORS; SYRINGE/TUBING EXT SETS AND NEEDLE-FREE CONNECTORS RECORDED MIXED FINDINGS. TWO OF THE RETURNED SPIROS CONNECTORS AND ONE OF THE 50ML SYRINGES RECORDED VARIOUS COMPONENT DAMAGES. NO OTHER ABNORMALITIES, DEFECTS WERE RECORDED WITH THE REMAINING DEVICES/SET-UPS. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED DEVICE SET-UPS/DAMAGED COMPONENTS DID CONFIRM MULTIPLE SOURCES WHERE THE COMPONENT DAMAGES WOULD CAUSE AIR ENTRY. THE QE ANALYSIS DETERMINED THE CHARACTERISTICS OF THE COMPONENT DAMAGES WERE CONSISTENT WITH INCORRECT TECHNIQUES, EXCESSIVE (BENDING) FORCES EXERTED BY THE LONG LEVER OF MATED COMPONENTS. THE REPORT ALSO NOTED THE THREAD DAMAGES WERE CONSISTENT WITH LEVERAGED TIGHTENING BETWEEN THE SPIROS FEMALE LUER AND THE 50ML SYRINGE MALE LUER THREADS. ADDITIONAL TESTING AND ANALYSIS OF THE SET-UP DEVICES (SPIROS ---> CLAVE ---> B BRAUN EXTENSION SET ASSEMBLIES) THAT WERE NOT DAMAGED RECORDED NO EVIDENCE OF LEAKAGE, AIR ENTRY WITHIN THE FLUID PATH. LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED (B)(4) LOT# 3070554 (MFG. DATE 06/2015) SHOWED (B)(4) WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: BASED ON THE "AS-RECEIVED" (B)(4) CONNECTOR DEVICES/SET-UPS THE REPORTED PRODUCT ISSUE WAS CONFIRMED WITH TWO OF THE RETURNED SPIROS CONNECTORS AND ONE OF THE 50 ML SYRINGES DUE TO VARIOUS COMPONENT DAMAGES. THE ROOT CAUSE(S) OF THE COMPONENT DAMAGES WERE ATTRIBUTABLE TO INCORRECT TECHNIQUES/USAGE CONDITIONS. ENGINEERING TESTING AND ANALYSIS OF THE REMAINING DEVICES/SET-UPS DID NOT REPLICATE THE REPORTED PRODUCT ISSUE. THE INVESTIGATION FINDINGS HAVE BEEN PROVIDED TO THE REPORTING DISTRIBUTOR/FACILITY FOR THEIR REVIEW AND RECORDS.

    Description of Event or Problem · 1

    INT'L. ((B)(6)) COMPLAINT RECEIVED REPORTING CONCERNS WITH "AIR IN LINE" DURING INFUSIONS WITH SET-UPS WHERE B BRAUN PERFUSOR EXT. LINES; B BRAUN 50ML SYRINGES AND (B)(4) SPIROS CONNECTORS WERE IN USE. THE INITIAL INFORMATION RECEIVED DESCRIBES INTERMITTENT OCCURRENCES DURING THE WEEK OF (B)(6) AND ARE DESCRIBED (AS TRANSLATED) AS FOLLOWS "...DURING THE INFUSION THE NURSE RESPONSIBLE FOR DRUG ADMINISTRATION NOTICED AIR IN THE PERFUSOR LINE. THE PROBLEM OCCURRED ON MULTIPLE OCCASIONS AND AT DIFFERENT TIMES.. NOT RIGHT AT THE BEGINNING ... THEY STOPPED THE INFUSION ... ". THERE WERE NO REPORTED PT. INJURIES; ADVERSE CONSEQUENCES. DEVICE RETURN: FOUR (4) USED (B)(4) SPIROS® CLOSED MALE CONNECTOR ; FOUR (4) USED B BRAUN 50ML SYRINGE, FOUR (4) USED B BRAUN TUBING EXTENSION TUBING AND FOUR (4) USED MICROCLAVE CLEAR CONNECTORS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768814 SPIROS CONNECTORS SPIROS CONNECTOR FPA ICU MEDICAL, INC. CH2000 3070554

    Patients

    Seq Age Sex Outcome Treatment
    1