BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUSA F7NR (HF/PS/1.6/L)

    MDR report key: 250163 · Received November 11, 1999

    Report

    Report Number
    1713747-1999-00295
    Event Type
    Death
    Date Received
    November 11, 1999
    Date of Event
    October 6, 1999
    Report Date
    October 15, 1999
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FJI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTIFIED BY CUSTOMER THROUGH FUSA MARKETING OF THIS PT EVENT. STATED COMPLAINT WITH THE USE OF THIS PRODUCT IS "GROSS HEMOLYSIS". NURSE MANAGER NOT AVAILABLE TODAY. QS SPOKE WITH ANOTHER NURSE FOR COMPLAINT INFO. AS CONFIRMED WITH HEALTH CARE PROFESSIONAL IN USER FACILITY, THE PT UNDERWENT AN UNEVENTFUL HEMODIALYSIS TREATMENT ON 10/9/1999. POST DIALYSIS THE PT HAD COMPLAINTS OF NAUSEA AND THE NURSING STAFF ATTRIBUTED THIS TO THE LOW POST WEIGHT. THE POST DIALYSIS WEIGHT WAS 0.9KG<ESTIMATED DRY WEIGHT. OTHER MEDICAL DEVICES IN USE WERE COBE C3 BTS (CARTRIDGE SET), MEDISYSTEMS FISTULA NEEDLES (15G), COBE CENTRYSYSTEM 3 DIALYSIS MACHINE. AWAITING CONCENTRATE INFO. FURTHER CLINICAL INFO REQUESTED. AWAITING BLOOD PRESSURE INFO. ROUTINE MONTHLY LABS WERE DRAWN PRE & POST TREATMENT. THE PT WAS DISCHARGED FROM THE OUTPATIENT UNIT STABLE TO HOME. LATER IN THE SAME DAY, THE PT DEVELOPED UNDEFINED SYMPTOMS AND WENT TO THE HOSP FOR TREATMENT/EVAL AND WAS ADMITTED. IT WAS FOUND BY LAB TESTING THAT THE PT'S BLOOD WAS GROSSLY HEMOLYZED. IN ADDITION SAMPLE DRAWN POST DIALYSIS ON SAME DAY WAS HEMOLYZED. HEMATOCRIT PREDIALYSIS WAS 36% HEMATOCRIT WITH ADMISSION (LATER IN SAME DAY) WAS 11%. PT BECAME DYSPNEIC AND WAS INTUBATED AND TRANSFERRED TO ICU. HE WAS TRANSFUSED 4 UNITS OF PACKED CELLS. REPORTEDLY THE PT'S HEMATOCRIT STABILIZED IN NEXT FEW DAYS. MEDICAL HISTORY OF PT SHOWED NO BLOOD DYSCRASIA, ANEMIA OTHER THAN THAT RELATED TO END STAGE RENAL DISEASE. THERE WAS NO HISTORY OF PANCREATITIS. ON 10/11/1999 PT EXPIRED. BY AUTOPSY CAUSE OF DEATH WAS INDENTIFIED AS PT HAD BEEN DISCHARGED STABLE. 10/18/1999 FURTHER INFO RECEIVED AND RECORDED ON PHONE LOG. BICART (ON-LINE BICARBONATE) PRODUCT #9-5198-L01 AND MINITECH LIQUIED ACID USED FOR CONCENTRATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSA F7NR (HF/PS/1.6/L) HIGH EFFICIENCY DIALYZER (SINGLE USE) FJI FRESENIUS MEDICAL CARE F7NR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H 10/6/1999 HEMODIALYSIS TREATMENT/COBE| BTS (CARTRIDGE).| CENTRYSYSTEM3 MACHINE/COBE C3