BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAMP PX KIT JR COMBO PEDIATRIC

    MDR report key: 2080012 · Received May 6, 2011

    Report

    Report Number
    2015691-2011-15464
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE PRODUCT ASSOCIATED WITH THIS COMPLAINT EVENT. HOWEVER, AT THE TIME OF THIS REPORT, THE SAMPLES HAVE NOT YET BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION INTO THIS LOT HAS CONFIRMED THAT THESE UNITS WERE INSPECTED AT THE WAREHOUSE AS PART OF A SAMPLING ACTIVITY CONDUCTED IN (B)(4) 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)(4) 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. OUR LAST COMMUNICATION WITH THE CUSTOMER ON (B)(6) 2011, INDICATES THAT THE PRODUCT WILL BE RETURNED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE AFTER THEIR RETURN AND EVALUATION, A SUPPLEMENTAL MDR WILL BE FILED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CASE WITH ALL UNITS UNSEALED WITH BLACK NUMBERS WRITTEN ON THE OUTSIDE OF PACKAGING. THERE WAS SUPPOSED TO BE ONLY 10 IN THE CASE BUT THE CUSTOMER STATES 12 ARE IN THE CASE.

    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