BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSABLE

    MDR report key: 2068011 · Received April 20, 2011

    Report

    Report Number
    2068011
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GENERAL ELECTRIC COMPANY
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A RECALL NOTICE FROM G.E. THAT THE INFUSABLE AND INFUSASCAN PRESSURE INFUSORS (PRODUCT CODES IN800012, IN800048, IN800020, IN900012, IN900048, IN900020, IN90006, IN900012) AND LOT #'S ( 2009- #2449-3659; 2010-#0010-3350) WERE BEING RECALLED BECAUSE THEY MIGHT LEAK AND NOT APPLY DESIRED PRESSURE TO THE IV SOLUTION BAG AND MIGHT SUBSEQUENTLY AFFECT THE RATE OF INFUSION, OR IF USED WITH AND ARTERIAL PRESSURE LINE COULD POTENTIAL AFFECT BLOOD PRESSURE READINGS WITH FALSE LOW RESULTS. AS THESE PRODUCTS ARE NOT STERILE, WE REMOVE THE OUTER PACKAGING AND SET THEM UP IN OUR CRITICAL AREAS FOR IMMEDIATE USE. WHEN WE RECEIVED THE RECALL NOTICE WE WERE UNABLE TO IDENTIFY WHICH PRODUCTS WERE FROM THE AFFECTED LOTS AND HAD TO DISCARD ALL OF THE PRODUCTS WE HAD. WE HAD TO HOLD BACK A FEW ITEMS, TAG THEM AS POTENTIAL RECALLS, NOTIFY STAFF AND MDS TO BE VIGILIANT WHEN USING THE PRODUCT BECAUSE OF THE POTENTIAL LEAKAGE IN ORDER TO HAVE A FEW PRESSURE BAGS ON HAND UNTIL WE COULD GET AN EMERGENCY REPLACEMENT SHIPMENT AS WE DID NOT HAVE AN ALTERNATIVE PRODUCT. THIS COULD HAVE BEEN AVOIDED IF THE MANUFACTURER WOULD PRINT THE PRODUCT & LOT NUMBER ON THE PRODUCT ITSELF. THE PRODUCT LABEL AND LOT NUMBER ARE ONLY PRINTED ON THE OUTER PACKAGING WHICH IS DISCARDED AND ON THE SHIPPING BOX. NO PATIENTS WERE HARMED, AND WE EXPERIENCED NO ISSUES WITH THE FEW REMAINING PRODUCTS WHILE WE AWAITED A NEW SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSABLE G.E. INFUSABLE KZD GENERAL ELECTRIC COMPANY * 2009-2449-3659 :2010-0010-3350
    2 INFUSASCAN G.E. INFUSASCAN PRESSURE INFUSOR KZD GENERAL ELECTRIC COMPANY * 2010-0010-3350

    Patients

    Seq Age Sex Outcome Treatment
    1 *