BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAMP PX KIT JR COMBO PEDIATRIC

    MDR report key: 2091821 · Received May 17, 2011

    Report

    Report Number
    2015691-2011-15551
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED UNITS CONFIRMED THAT THE PACKAGES WERE UNSEALED AND HAD BLACK NUMBERS WRITTEN ON THE OUTSIDE OF THE PACKAGING . THE PACKAGING WAS OPENED APPROXIMATELY HALF WAY AROUND THE SEAL AREA. NO VISIBLE DEFECT WAS OBSERVED FROM THE SEAL AREA OF THE PACKAGE. THE PRODUCT APPEARED NOT USED. NO PRIMING SOLUTION WAS FOUND INSIDE THE KIT. ALL LUER VENTED CAPS WERE STILL ATTACHED TO THE KIT. PAPER BANDS WERE STILL ATTACHED TO TUBING COILS. IT WAS DETERMINED THAT THESE UNITS HAD BEEN INSPECTED AT THE WAREHOUSE AS PART OF A SAMPLING ACTIVITY CONDUCTED IN (B)(6) 2010 BY EDWARDS LIFESCIENCES PERSONNEL. THE UNITS HAD BEEN RETURNED TO THE EDWARDS MANUFACTURING FACILITY FOR FURTHER TESTING AND DISPOSAL; HOWEVER, A BREAKDOWN IN THE PROCESS LED TO RELEASE OF THE AFFECTED UNITS INTO THE FIELD. AS A RESULT, THE 22 UNITS SAMPLED FROM THIS LOT OF PRODUCT WERE SENT TO TWO CUSTOMERS, BOTH OF WHOM FILED COMPLAINT REPORTS IN (B)(6) 2011. TWENTY-TWO SEPARATE MDRS WILL BE FILED TO ACCOUNT FOR EACH UNIT. AS RECEIVED, THE INDIVIDUAL UNITS ARE DEFACED WITH BLACK MARKER AND THE PACKAGING FOR EACH UNIT IS BLATANTLY OPEN. IN ADDITION, LABELING ON EACH UNIT STATES: "CONTENTS STERILE AND FLUID PATH NONPYROGENIC IF PACKAGE IS UNDAMAGED OR UNOPENED. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED". AS A RESULT, IT WOULD BE CLEAR TO ANY MEDICAL PRACTITIONER THAT THE PRODUCTS ARE NOT ACCEPTABLE FOR USE. THE COMPLAINT WAS CONFIRMED TO BE RELATED TO AN INTERNAL PROCESS FAILURE. AN IN-DEPTH INVESTIGATION WAS CONDUCTED TO DETERMINE THE CAUSE OF THE PROCESS FAILURE AND CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A CASE OF 10 DEVICES WITH THE PACKAGING OPENED AND NUMBERS WRITTEN IN BLACK INK ON THE OUTSIDE OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAMP PX KIT JR COMBO PEDIATRIC DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR VMP448PX 58932635

    Patients

    Seq Age Sex Outcome Treatment
    1