BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL

    MDR report key: 4861447 · Received June 22, 2015

    Report

    Report Number
    3005162618-2015-00035
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 21, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MACHINE SETTINGS: 2K 2.5 CA ACID; SODIUM 140 MEQ/L; BICARB 3 MEQ/L; BLOOD FLOW RATE 400-235; DIALYSATE FLOW RATE 600; ULTRAFILTRATION GOAL 6.3L THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REVIEWING PATIENT MEDICAL RECORDS AND TREATMENT DATA INFORMATION REGARDING THE REPORTED HYPOTENSION DURING HEMODIALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A QUESTION WAS RECEIVED FROM A HEMODIALYSIS CLINIC ADMINISTRATOR ABOUT THE POSSIBILITY OF AN ALLERGIC REACTION TO GRANUFLO. FOLLOW UP WAS ACCOMPLISHED WITH THE FACILITY ADMINISTRATOR (FA). THE PATIENT HAD BEEN HOSPITALIZED IN (B)(6) AND (B)(6) FOR RESPIRATORY FAILURE, SEPSIS WITH WOUND INFECTION, PNEUMONIA, ACUTE-ON-CHRONIC RENAL FAILURE, AND SEVERE DE CONDITIONING. ACCORDING TO THE FA, THIS PATIENT WHO WAS PARAPLEGIC FROM A MOTOR VEHICLE ACCIDENT, CHRONICALLY VENTILATOR DEPENDENT, BEDBOUND, AND IN A NURSING HOME, ATTEMPTED TO DIALYZE 7 TIMES AT HER FACILITY WITHOUT COMPLETING ANY TREATMENTS DUE TO SHORTNESS OF BREATH, ANXIETY AND FREQUENT HYPOTENSION. SHE REPORTS HIS SYMPTOMS WOULD RESOLVE SHORTLY AFTER HIS BLOOD WAS RETURNED. SHE STATES THEY CHANGED THE DIALYZER WITHOUT ANY CHANGES IN PATIENT'S SYMPTOMS. THEY CHANGED THE GRANUFLO FOR NATURALYTE (IN GALLON) WITHOUT ANY CHANGE IN SYMPTOMS. THE FA REPORTED, "I HONESTLY DON'T THINK IT'S THE GRANUFLO." PATIENT HEMOGLOBIN WAS "7"(LOW). THE PATIENT WAS HOSPITALIZED BECAUSE HE HAD NOT BEEN ABLE TO RECEIVE ANY APPRECIABLE AMOUNT OF DIALYSIS DURING THIS TIME, BUT THE FA SAID NO TREATMENT WAS REQUIRED. CREATININE WAS FOUND TO BE 1.6 AND DIALYSIS WAS DISCONTINUED. THE PATIENT NO LONGER REQUIRES DIALYSIS AND IS DOING WELL. THERE IS NO SAMPLE AVAILABLE. IT WAS DISCARDED. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE (B)(6) 2015 TREATMENT SHEET, THE PATIENT DEVELOPED DIFFICULTY BREATHING AND INCREASED ANXIETY AFTER 25 MIN OF TREATMENT. TREATMENT WAS ENDED AT THAT TIME AND PATIENT SENT TO HOSPITAL VIA AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402393 GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R OPTIFLUX 160NRE DIALYZER