BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO DRY ACID CONCENTRATE

    MDR report key: 6261559 · Received January 17, 2017

    Report

    Report Number
    6261559
    Event Type
    Death
    Date Received
    January 17, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 11, 2017
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KPO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CEFAZOLIN GIVEN FOR LEFT ARM HAD DRAINAGE. .

    Description of Event or Problem · 1

    ON (B)(6) 2016, PT DIALYZED 4 HRS OF ORDERED 4 HR DIALYSIS TREATMENT. DURING TREATMENT, PULSES RANGED FROM 58 63; SBT FROM 100 140; DBP FROM 36-52. CEFAZOLIN 2 GRAMS IV WAS ADMINISTERED. POST DIALYSIS VS: H/P 115/36; PULSE-G1 REGULAR; RESP-1G; TEMP-97.0; 5.3 KG REMOVED. POST ASSESSMENT STATES: "TIRED, ORIENTED, SITTING B/P 115/36, P 61. L ARM STILL DRAINING SEROSANGUINOUS FLUID AND YELLOWISH PUS DRAINED FROM OPEN AREA - CLEANED WITH ALCOHOL - ANTIBIOTIC OINTMENT AND GAUZE APPLIED. CEFAZOLIN GIVEN IV, POST WT (B)(6) KG - PULLED 5.3 KG." PT WENT HOME AFTER TREATMENT ACCOMPANIED BY HUSBAND. HE WENT OUTSIDE AND WHEN HE RETURNED TO THE INSIDE OF THE HOUSE, HE FOUND HER WITHOUT A PULSE. CPR WAS INITIATED, HOWEVER, THE PT COULD NOT BE REVIVED. PT WAS NEW TO DIALYSIS, STARTING TREATMENT AT THIS CLINIC (B)(6) 2016. ON (B)(6) 2016, IT WAS DISCOVERED THAT GRANUFLO 2.0K WAS BEING DELIVERED TO PATIENTS WITH ORDERS FOR 3.0K DIALYSATE AND THE GRANUFLO 3.0K WAS BEING DELIVERED TO PATIENTS WITH ORDERS FOR 2.0K DIALYSATE. UPON INVESTIGATION, IT WAS DETERMINED THAT THIS HAD BEEN OCCURRING FROM (B)(6) 2016. ORDERED DIALYSATE FOR THIS PT WAS G3231. THE PT DIALYZED ON G2231 FROM (B)(6) 2016. LOT NUMBERS FOR G2231: (B)(6): 16KXGF004; (B)(6): 16KXGF004; EXPIRATION DATE: 8/31/2017. ADD'L EXPIRATION DATE: 9/30/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41542 GRANUFLO DRY ACID CONCENTRATE GRANUFLO KPO FRESENIUS MEDICAL CARE G2231 16KXGF004
    41543 GRANUFLO DRY ACID CONCENTRATE GRANUFLO KPO FRESENIUS MEDICAL CARE 2.0K
    41544 GRANUFLO DRY ACID CONCENTRATE GRANUFLO KPO FRESENIUS MEDICAL CARE 2.25CA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death