BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVACLEAR MAX

    MDR report key: 3232406 · Received July 18, 2013

    Report

    Report Number
    3006552611-2013-00004
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GAMBRO RENAL PRODUCTS
    Product Code
    KDI
    PMA / PMN Number
    K060195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR DEVICES FROM SAME LOT OF THE ACTUAL DEVICE INVOLVED IN INCIDENT WERE EVALUATED AND NO DEFECTS WERE FOUND. GAMBRO HAS NO INFORMATION TO SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT AND GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO THE ICU AFTER EVALUATION IN THE ER FOR LETHARGY, HYPERTENSION AND HYPERKALEMIA. THE PATIENT HAS A HISTORY OF CHRONIC RENAL FAILURE AND CHRONIC DIALYSIS BUT WAS UNKNOWN TO THE FACILITY AND NEPHROLOGY GROUP. UPON ADMISSION TO THE ICU, THE PHYSICIAN ORDERED A DIALYSIS TREATMENT FOR THE PATIENT. WITHIN THE FIRST FEW MINUTES OF THE DIALYSIS TREATMENT, THE PATIENT BECAME RESTLESS, SAT UP IN BED SCREAMING, HAD AN INCREASE IN BLOOD PRESSURE, EXPERIENCED A SEIZURE AND CODED. THESE SYMPTOMS ARE CONSISTENT WITH A TYPE A DIALYZER REACTION WHICH IS AN ALLERGIC REACTION TO THE DIALYZER. THERE HAD BEEN NO PROBLEMS OR MACHINE ALARMS DURING THE TREATMENT. THE BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS RETURNED TO THE PATIENT AND TREATMENT ENDED. THE PATIENT WAS SUCCESSFULLY RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334465 REVACLEAR MAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO RENAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention