BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY

    MDR report key: 3255622 · Received July 26, 2013

    Report

    Report Number
    1713747-2013-00284
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    January 5, 2012
    Report Date
    June 27, 2013
    Manufacturer
    OGDEN MFG
    Product Code
    KDI
    PMA / PMN Number
    K043244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INDICATED THE PATIENT SUFFERED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY THE POST MARKET CLINICAL STAFF AND PHYSICIAN. ACCORDING TO THE MEDICAL RECORDS (1471 PAGES) PROVIDED BY THE PLAINTIFF'S ATTORNEY; MEDICAL RECORDS INDICATE PATIENT RECEIVED UNEVENTFUL HEMODIALYSIS ON (B)(6) 2013; AND ACCORDING TO THE TREATMENT NOTES PATIENT WAS DISCHARGED HOME IN STABLE CONDITION AND WITHOUT COMPLAINTS TO HOME. THE LIMITED INFO AVAILABLE REVEALED PATIENT TO BE FOUND IN PEA, AND TAKEN TO THE CATH LAB FOR AN ACUTE MYOCARDIAL INFARCTION. THERE IS NO HISTORY OF DEFECTIVE OR OUT OF SPECIFICATION PRODUCTS USED IN THIS TIME FRAME. THE HOSPITAL DISCHARGE SUMMARY DOCUMENTS THE PATIENT EXPIRED ON (B)(6) 2012 WITH THE STATED CAUSE OF DEATH: CARDIOGENIC SHOCK SECONDARY TO ACUTE MYOCARDIAL INFARCTION. A DEATH CERTIFICATE OR AUTOPSY REPORT HAS NOT BEEN PROVIDED. A MFG REVIEW WAS PERFORMED ON THE GRANUFLO AND NATURALYTE AND THERE WAS NO EVIDENCE OF A MFG RELATED CAUSE. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. IF ADD'L INFO IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. A SYSTEM LEVEL INVESTIGATION IS BEING PERFORMED TO INCLUDE ALL CONCOMITANT FRESENIUS PRODUCTS USED AT THE TIME OF THE EVENT. PLEASE REFERENCE MDR REPORT NUMBERS: 1225714-2013-00092, 00093. 00102, 00103, 00108, 00107, 2937457-2013-00106, 00107, 1713747-2013-00284, 00285, 8030665-2013-00480, 00481, 1713747-2013-99920 AND 99921.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2008- PATIENT BEGAN HEMODIALYSIS. ON (B)(6) 2011- ANNUAL HD HISTORY AND PHYSICAL. ON (B)(6) 2012 - HD TREATMENT SHEET. TREATMENT INITIATED AND COMPLETED WITHOUT DIFFICULTY. DISCHARGED TO HOME AMBULATORY. ON (B)(6) 2012 AND (B)(6) 2013- TREATMENT INITIATED AND COMPLETED WITHOUT DIFFICULTY. DISCHARGED TO HOME AMBULATORY. ON (B)(6) 2012 - HOSPITAL DEATH SUMMARY- PATIENT PRESENTED WITH DIZZINESS AND UNRESPONSIVENESS. EMS WAS SUMMONED TO RESIDENCE AND PATIENT WAS FOUND TO BE IN PULSELESS ELECTRICAL ACTIVITY (PEA). EPISODE OF V-TACH IN EMERGENCY ROOM REQUIRING DEFIBRILLATION AND INITIATION OF AMIODARONE. EKG CONSISTENT WITH ACUTE ANTERIOR MI AND HE WAS TAKEN EMERGENTLY TO CATH LAB. TRANSFERRED TO ICU. EXPIRED ON (B)(6) 2012. CAUSE OF DEATH: CARDIOGENIC SHOCK SECONDARY TO ACUTE MYOCARDIAL INFARCTION. ALTHOUGH REQUESTED, MEDICAL RECORDS, TREATMENT SHEETS, AND/OR HOSPITAL PROGRESS NOTES HAVE NOT BEEN PROVIDED. A DEATH CERTIFICATE AND/OR AUTOPSY REPORT WAS NOT PROVIDED. MEDICATIONS: SIMVASTATIN, ASPIRIN, NEURONTIN, CALCIUM ACETATE, TEMAZEPAM, VITAL-D, SENSIPAR, EFFEXOR, LISINOPRIL, COREG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350724 OPTIFLUX 180NRE DIALYZER FINISHED ASSY NONE KDI OGDEN MFG

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R