BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX REVACLEAR DIALYZER MAX

    MDR report key: 2141131 · Received June 22, 2011

    Report

    Report Number
    3006552611-2011-00008
    Event Type
    Injury
    Date Received
    June 22, 2011
    Manufacturer
    GAMBRO RENAL PRODUCTS INC.
    Product Code
    KDI
    PMA / PMN Number
    K060195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DIALYZER INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION. A RETAINED SAMPLE FROM THE SAME LOT NUMBER OF SUSPECT DEVICE WAS ANALYZED AND THERE WERE NO NON CONFORMITIES. THERE ARE NO COMPLAINTS FROM LOT # C411200201 EXCEPT FOR THE TWO DIALYZERS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    EIGHTEEN MINUTES FOLLOWING THE INITIATION OF THE HEMODIALYSIS TREATMENT, MACHINE GENERATED THE "BLOOD LEAK DETECTED" ALARM. THERE WERE NO VISIBLE SIGNS OF A BLOOD LEAK BUT THE FLUID AT THE DRAIN TESTED POSITIVE FOR BLOOD. THE TREATMENT WAS DISCONTINUED AND THE PATIENT DISCHARGED HOME. FOLLOWING DISCHARGE FROM THE CLINIC, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR COMPLAINTS OF A RASH, HEMATOMA AT THE SITE OF HIS LEFT A/V FISTULA, DIFFICULTY SWALLOWING, AND THROAT DISCOMFORT. THE MEDICAL IMPRESSION ON ADMISSION WAS AS FOLLOWS: "MOST LIKELY ALLERGIC REACTION DURING HD AND RULE-OUT ACUTE CORONARY SYNDROME." THE PATIENT'S BLOOD WORK REVEALED AN ELEVATED LDH AND D DIMER WITH DECREASED HAPTOGLOBIN. THERE WAS NO OBVIOUS SCHISTOCYTES OR SPHEROCYTES TO SUGGEST ACTIVE HEMOLYSIS AND IT WAS DIFFICULT TO ESTABLISH A DEFINITIVE DIAGNOSIS, HOWEVER, THE TREATING PHYSICIAN BELIEVED THE PATIENT HAD EXPERIENCED SOME ELEMENT OF HEMOLYSIS. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR MAX DIALYZER WERE ALL DISCARDED. THE FIRST DIALYZER IS ASSOCIATED WITH MFR REPORT #3006552611-2011-00007. THE PHOENIX MACHINE WAS NOT INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX REVACLEAR DIALYZER MAX KDI GAMBRO RENAL PRODUCTS INC. C411200201

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization BICART: (LOT # UNK)| PHOENIX MACHINE: (SN UNK)| CARTRIDGE BLOOD TUBING: (LOT # UNK)