BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI SET

    MDR report key: 3952303 · Received June 19, 2014

    Report

    Report Number
    8030665-2014-00499
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    January 16, 2013
    Report Date
    May 20, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW: PLANT INVESTIGATION: COMPLAINT SAMPLE IS NOT AVAILABLE, AND THE LOT NUMBER OF PRODUCT INVOLVED IN THIS INCIDENT IS UNKNOWN. HOWEVER, A THREE MONTH SALES AND SHIPPING SEARCH TO THE CLIENT SITE DEMONSTRATED 7 LOTS. ACCORDING TO THE SAP SYSTEM NO PRODUCT IS AVAILABLE FROM THESE LOTS ON DISTRIBUTION CENTERS TO BE ANALYZED. THE ENTIRE LOTS HAVE BEEN SOLD AND DISTRIBUTED. DEVICE HISTORY RECORDS REVIEW WAS PERFORMED ON POTENTIAL RELATED LOTS. NO NONCONFORMANCE REPORTS OR OTHER ABNORMALITIES DURING THE ASSEMBLY OF THESE LOTS WERE FOUND. THE PRODUCT INVOLVED MET CURRENT SPECIFICATIONS. A SEARCH WAS CONDUCTED IN PILGRIM COMPLAINTS SYSTEM, NO ADD'L COMPLAINTS WITH THE SAME SYMPTOM CODE WERE FOUND FOR ANY OF THE POTENTIAL RELATED LOTS. MEDICAL RECORDS INFO REVIEWED: THIS EVENT HAS BEEN REPORTED AS A SERIOUS INJURY, ALTHOUGH IT IS UNDETERMINED IF THERE IS A REASONABLE SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE PRODUCT(S) AND THE EVENT. THERE IS NO HISTORY OF SPECIFIC MALFUNCTION OR PRODUCT BEING OUT OF SPECIFICATIONS. THE ALLEGATIONS OF SERIOUS INJURY REMAIN SPECULATIVE IN NATURE. THE EVENT REPORTED ON THIS PATIENT INVOLVES SIX SEPARATE PRODUCTS AND ASSOCIATED WITH MDR'S 2937457-2014-01145, 1713747-2014-00315, 2937457-2014-00499, 1225714-2014-00513, 1225714-2014-00514, AND 1713747-2014-99980.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY. THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(4) 2013, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360074 COMBI SET FJK FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death FMC DIALYZER| NATURALYTE| 2008K HEMODIALYSIS SYSTEM| GRANUFLO| FMC SALINE