BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETSOURCE NANOCLAVE CONNECTORS

    MDR report key: 3973103 · Received June 5, 2014

    Report

    Report Number
    2025816-2014-00052
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING EVENTS: PN ALARM SILENCE, IV SET DISCONNECTED, SWABBED NANOCLAVE AND SET RECONNECTED INFUSIONS RESTARTED. WITHIN 3-4 MINS AN OCCLUSION ALARMED OCCURRED AGAIN ON PN LINE. BOTH INFUSIONS WERE TURNED OFF, ALL IV AND EXTENSION SETS AND NANOCLAVES WERE CHANGED. INFANT'S PICC DRESSING TAKEN DOWN, REPOSITIONED PICC CATHETER HUB, CATHETER FLUSHED WITHOUT DIFFICULTY, DRESSING REAPPLIED AND ARM-BOARD APPLIED TO STABILIZE THE INFANT'S ARM. RESUMED INFUSIONS-PN MODULE ALARMED A 3RD TIME. INFUSIONS STOPPED, NANOCLAVES REPLACED ON TRI-LEG EXTENSION SET AND VYCON PICC CATHETER HUB." INVESTIGATIONS ARE IN PROGRESS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING OCCLUSION ISSUES ON SET-UPS WHERE THE Z3769 NANOCLAVE CONNECTORS WERE IN USE. THE INFO RECEIVED REPORTS DURING FACILITIES TRIAL OF THE NANOCLAVE, THERE HAVE BEEN FOUR INCIDENTS WHERE "..CENTRAL LINES (UVCS AND PICCS) HAVE BECOME OCCLUDED USING THE NANOCLAVE. NURSES...HAVE TROUBLESHOT BY CHANGING OUT CONNECTORS, CHANGING OUT PUMPS, REDRESSING AND REPOSITIONING PICC LINES ALL TO NO AVAIL..." SET-UPS AND USAGE REPORTED AS FOLLOWS: "DAILY IV SET AND EXTENSION SET CHANGES FOR PN 12.5% AND LIPIDS-THERAPY RESUMED THROUGH A 1 FR VYCON PICC VIA CAREFUSION PUMP PN MODULE INFUSION RATE: 4.3MUHR, LIPIDS MODULE: SYRINGE PUMP; INFUSION RATE: 0.46MUHR APPROXIMATELY 10 MINS AFTER THE INFUSION WAS STARTED AN OCCLUSION ALARM OCCURRED ON THE PN LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328418 SETSOURCE NANOCLAVE CONNECTORS NANOCLAVE CONNECTOR FPA ICU MEDICAL, INC. Z3769 38-556-JW

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ON BBRAUN SMLLBORE TRIPLE-LEG EXT.| EXT. SET W/0.2 MICRON FILTER ATTACHED TO NANOCLAVE| CAREFUSION PUMPSET WITH CODAN MINIBORE,