BEUDAMED
    FDA Adverse Event Other Summary report: N

    8" EXT SET W/MICROCLAVE (PCA RING) BCV-CLAVE

    MDR report key: 1568306 · Received June 10, 2009

    Report

    Report Number
    2025816-2009-00013
    Event Type
    Other
    Date Received
    June 10, 2009
    Date of Event
    April 30, 2009
    Report Date
    May 6, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY AND ICU MEDICAL INC INITIATED IMMEDIATE CORRECTIVE AND PREVENTATIVE MEASURES. THE MFR'S ANALYSIS HAS IDENTIFIED THAT BY RECONFIGURING THE ANALGESIC LINE AND ASSEMBLING THE PCA YELLOW RING LABEL ON THE Y-CLAVE WITH BACK CHECK VALVE AN UNINTENDED MEDICATION DELIVERY WOULD NOT OCCUR UNDER THE ABOVE DESCRIBED EXTREME CIRCUMSTANCES. CURRENT B33031, REV. 03 BUILDS REFLECTS THESE CHANGES. FACILITY HAS RETURNED B33031 REV. 02 LOT INVENTORY TO DISTRIBUTOR/MFR FOR REPLACEMENT SETS BUILT TO THE REV. 03 CONFIGURATION. RECORD REVIEW: A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT #1561373 (MFG DATE 03/2009) SHOWS (B)(4). A REVIEW OF THE COMPLAINT DATABASE IDENTIFIED NO ADDITIONAL REPORTS. ADDITIONAL MEASURES TAKEN BY THE MFR: ALL SET CONFIGURATIONS UTILIZING SAME/SIMILAR COMPONENTS WERE REVIEWED AND ANALYZED. THERE WERE NO ADDITIONAL SETS CONFIGURED IN THIS MANNER.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED IDENTIFYING FLOW AND DELIVERY CONCERNS WITH ICU MEDICAL MFG. LIST #B33031 CUSTOM DESIGNED EXTENSION SETS LABELED COMPONENT CONFIGURATION. THE B33031 SET IS CONFIGURED FROM THE PROXIMAL END WITH A MICROCLAVE CONNECTOR/WITH A YELLOW LABELED PCA RING CONNECTED TO 2" NON-DEHP FROSTED CONNECTED TO A Y CLAVE W/BCV (BACK CHECK VALVE) BONDED TO 3.5" NON-DEHP TUBING CONNECTED TO A ROTATING MALE LUER ADAPTOR AT THE DISTAL END (ALL REF CONNECTIONS BONDED). THE B33031 CUSTOMER EXT SET IS USED BY TRAINED CLINICAL PERSONNEL PER THE HOSPITAL'S VALIDATED IV PROTOCOLS. THE SET'S DURAL LUMAN/TUBING LINES (MAINTENANCE AND ANALGESIC LINES) ARE RUN VIA PUMP INFUSIONS IN CONJUNCTION WITH ALARMED MONITORING EQUIPMENT. FACILITY CLINICIANS HAVE RECENTLY IDENTIFIED THAT THIS SET'S CONFIGURATION COULD UNDER A SPECIFIC SET OF MULTIPLE CONDITIONS IMPACT PROPER MEDICATION FLOW/DELY. SHOULD THE SET'S TUBING LINES KINK AND THE MAINTENANCE LINE RUN DRY AND THE PUMP ALARM IGNORED/UNATTENDED MULTIPLE TIMES (EVERY SIX MINUTES FOR APPROX 18 MIN.) OR THE PUMP ALARM RESET, IMPROPER MEDICATION INFUSION COULD OCCUR. ICU MEDICAL'S PRODUCT MANAGEMENT'S ANALYSIS OF THE PLACEMENT/LOCATION OF THE SET'S COMPONENTS HAVE CONCURRED THAT IT IS POSSIBLE UNDER THE ABOVE DESCRIBED CIRCUMSTANCES FOR A POTENTIAL UNINTENDED BOLUS DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8" EXT SET W/MICROCLAVE (PCA RING) BCV-CLAVE TUBING EXTENSION SET FPA ICU MEDICAL, INC. B33031 1561373

    Patients

    Seq Age Sex Outcome Treatment
    1 INFUSION PUMP, MFR, MAKE, MODEL UNK