BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG SPIKE W/CLAVE, DRY SPIKE ADAPTER

    MDR report key: 5014893 · Received August 13, 2015

    Report

    Report Number
    2025816-2015-00087
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW SHOWED 950 EACH MANUFACTURED, TESTED, INSPECTED AND RELEASED WITH NO ANOMALIES IN APRIL 2015.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS: 08/12/2015 - RECEIVED THE FOLLOWING DEVICES. ONE USED CH-12, BAG SPIKE W/CLAVE, DRY SPIKE ADAPTER, LOT NUMBER 3032795 (MANUFACTURED APRIL 2015), ONE USED SECURE 100ML IV BAG, ONE USED ACCESSORY PUMPSET MAKE/MODEL UNK, ONE NEW POPPY POCKET INFUSION FREEDO, THREE NEW CH-12, BAG SPIKE W/CLAVE, DRY SPIKE ADAPTER, LOT NUMBER 3032795 (MANUFACTURED APRIL 2015). THE CH-12 IS CONFIRMED TO BE SEPARATED AT THE BONDING SITE BETWEEN THE DRY SPIKE AND THE BAG SPIKE ADAPTER. INVESTIGATION: A MATING DEVICE SPIKE WAS INSERTED INTO THE DRY SPIKE ADAPTER AND THE TIP OF THE SPIKE WAS DAMAGED (BLUNTED). THIS KIND OF SPIKE BLUNTING CAN CAUSE AN INCREASE IN CONNECTION FORCES BETWEEN THE MATING DEVICE SPIKE AND DRY SPIKE ADAPTER. THE SOLVENT BOND BETWEEN THE DRY SPIKE ADAPTER AND SPIKE APPEARED TO HAVE FULL SOLVENT COVERAGE. ANALYSIS SUMMARY: THE COMPLAINT OF CH-12 BAG SPIKE WITH DRY SPIKE ADAPTER SEPARATION WAS CONFIRMED. THE DRY SPIKE ADAPTER WAS SEPARATED FROM THE BAG SPIKE AT THE SOLVENT BOND. THE BOND APPEARED TO BE GOOD WITH FULL SOLVENT DISTRIBUTION AT THE BOND INTERFACE. SUBSEQUENT TESTING OF THE NEW/UNUSED CH-12 BOND INTEGRITY CONFIRMED THAT THE BONDS ARE ADEQUATE. THE DAMAGED SPIKE TIP INSERTED INTO THE DRY SPIKE ADAPTER SUGGESTS THAT GREATER THAN NORMAL FORCES MAY HAVE BEEN APPLIED TO THE DRY SPIKE ADAPTER/BAG SPIKE BOND INTERFACE WHILE INSERTING THE SPIKE INTO THE DRY SPIKE ADAPTER.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED STATING " PT WAS SENT HOME WITH A CADD PUMP SET UP IN A POPPY POCKET. THE CH-12 FAILED UPON PT SITTING DOWN AT HOME. THE CH-12 BROKE IN HALF, ALLOWING CHEMO TO SPILL ALL OVER PT. A 5FU WAS THE CHEMO BEING DELIVERED". NO SERIOUS PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535754 BAG SPIKE W/CLAVE, DRY SPIKE ADAPTER BAG SPKE W/CALVE, DRY SPIKE ADAPTER FPA ICU MEDICAL, INC. CH-12 3032795

    Patients

    Seq Age Sex Outcome Treatment
    1 NI