BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADEX FLEX FLOW SYSTEM

    MDR report key: 1340106 · Received March 6, 2009

    Report

    Report Number
    3003504604-2006-00003
    Event Type
    Injury
    Date Received
    March 6, 2009
    Date of Event
    November 11, 2006
    Report Date
    December 26, 2006
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    PMA / PMN Number
    K013733
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM DISPOSABLE CIRCUIT WAS DISPOSED OF; THEREFORE, A PRODUCT EVALUATION WAS NOT COMPLETED. THE SYSTEMS CONSOLE WAS RETURNED TO THE COMPANY FOR EVALUATION. THE CONSOLE SERIAL # WAS IDENTIFIED AHEAD OF TIME, ALLOWING THE COMPANY TO COMPLETE A HISTORY REVIEW PRIOR TO THE PRODUCT RETURN. THE REVIEW INDICATES NO ABNORMALITIES IN MANUFACTURING, FINAL ACCEPTANCE, QUALITY CONTROL OR THE SERVICE PROCESSES ASSOCIATED WITH THE CONSOLE. THE PRODUCT ALARM HISTORY WAS THEN REVIEWED BY THE COMPANY AND INDICATES THE PRODUCT WORKED WITHIN SPECIFICATION. THE FINAL SERVICE REPORT INDICATES THE PRODUCT WAS OPERATING AS PRESCRIBED AND WAS RETURNED TO THE CUSTOMER FOR USE. PTS WHO ARE EITHER ON ULTRAFILTRATION OR IV DIURETICS CAN BECOME HYPOVOLEMIC, WHEN THE INTERSTITIAL FLUID RECRUIT RATE IS EXCEEDED BY THE REMOVAL RATE FROM THE INTRAVASCULAR SPACE. IT CAN BE DIFFICULT TO DETERMINE THE RECRUITMENT RATE (PLASMA REFILL RATE) BECAUSE IT VARIES OVER TIME AND IS DEPENDENT ON A NUMBER OF FACTORS. NORMALLY ONLY ONE METHOD OF FLUID REMOVAL IS USED AT A TIME. IT IS UNUSUAL TO COMBINE THE PHARMACEUTICAL AND MECHANICAL THERAPIES BECAUSE ONE CAN POTENTIATE THE OTHER MAKING IT DIFFICULT TO REFINE THE THERAPIES TO MATCH THE PLASMA REFILL RATE. THE OCCURRENCE OF THIS TYPE OF EXPERIENCE IS COMMENSURATE WITH THE COMPANY RISK ASSESSMENT. THE TOTAL SYSTEM HAS PERFORMED WITHIN REQUIRED SPECIFICATIONS AND AS INTENDED. THE HEALTH FACILITY WILL BE MONITORED AS PART OF ROUTINE COMPLAINT HANDLING AND REPORTING PROCEDURES. THE COMPANY CONSIDERS THIS INVESTIGATION CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT HOSPITALIZATION WAS PROLONGED BY 7 DAYS. A FEMALE WITH HISTORY OF NEPHRECTOMY, CHRONIC RENAL INSUFFICIENCY AND DIASTOLIC HEART FAILURE WAS TREATED FOR 3 DAYS WITH ULTRAFILTRATION WITH A TOTAL AMOUNT OF 12.75 LITERS OF ULTRAFILTRATE REMOVED. PT HAD AN INR OF OVER 3, WAS GIVEN ADDITIONAL ANTICOAGULATION AND IV LASIX DURING THE UF THERAPY. THE PT HAD A NUMBER OF NON-SYMPTOMATIC HYPOTENSIVE EVENTS THAT REQUIRED THE UF RATE TO BE DECREASED OR TURNED OFF UNTIL THE BLOOD PRESSURE STABILIZED. THIS PT PRESENTED WITH CHRONIC RENAL INSUFFICIENCY AND HAD A SUSPECTED RETROPERITONEAL BLEED THAT REQUIRED AN IV CONTRAST X-RAY EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUADEX FLEX FLOW SYSTEM S-100, AQUADEX FLEX FLOW CONSOLE KDI CHF SOLUTIONS, INC. A1100 222

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization