BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1691401 · Received April 20, 2010

    Report

    Report Number
    8030638-2010-00001
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 20, 2010
    Report Date
    March 22, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE BLOOD TUBING SET USED AT THE TIME OF THE DIALYSIS TREATMENT WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS. RETAINED SAMPLES FROM SAME LOT NUMBER 01R158218 WERE VISUALLY INSPECTED, FUNCTIONAL AND DIMENSIONAL TESTING PERFORMED WITH NO FAILURES DETECTED. THE PHOENIX MACHINE WAS INSPECTED BY THE FACILITIES BIOMEDICAL TECHNICIAN AND A GAMBRO TECHNICAL SERVICE TECHNICIAN AND BOTH CONCLUDED THE PHOENIX MACHINE WAS OPERATING WITHIN MFR'S SPECIFICATIONS.

    Description of Event or Problem · 1

    A PT COMPLETED HIS HEMODIALYSIS TREATMENT ON A PHOENIX MACHINE WITH A CARTRIDGE BLOOD TUBING SET AND BAXTER DIALYZER. THE NURSE HAD SOME RESISTANCE WHEN CANNULATING HIS ACCESS AND IT WAS NOTED THE ARTERIAL AND VENOUS PRESSURES WERE SLIGHTLY OUTSIDE OF HIS NORMAL READINGS. AT THE END OF TREATMENT, THE PT REPORTED HE PASSED CLOTS WHEN URINATING. HE WAS INSTRUCTED TO GO TO THE ER. THE PT WAS HOSPITALIZED AND DIAGNOSED WITH COOMBS-POSITIVE IMMUNE-MEDIATED HEMOLYTIC ANEMIA, ACUTE HEPATITIS AND PANCREATITIS. THE BLOOD TESTS ARE INDICATIVE OF A MEDICAL HEMOLYSIS. THE NEPHROLOGIST RHEUMATOLOGIST, AND ONCOLOGIST TREATING THIS PT, COLLECTIVELY CONCLUDED THE CAUSE OF THE HEMOLYSIS IS MOST LIKELY A RESULT OF IDIOPATHIC THROMBOTIC THROMBOCYTOPENIC PURPURA. THE NURSE CHECKED THE BLOOD LINES FOR ANY KINKS. NO KINKS WERE FOUND. THE NURSE ALSO DID NOT OBSERVE THE LINES BOUNCING AND DID NOT HEAR ANY UNUSUAL NOISES COMING FROM THE BLOOD LINES. BLOOD TUBING SET WAS DISCARDED AND IS NOT AVAILABLE FOR INSPECTION. THE HOSPITAL BIOMED TECHNICIAN AND A GAMBRO SERVICE TECHNICIAN INSPECTED THE PHOENIX MACHINE. NO PROBLEMS WERE FOUND. THE GAMBRO SERVICE TECHNICIAN AUTHORIZED THE RETURN OF THE MACHINE TO CLINICAL USE. IT HAS BEEN RETURNED TO CLINICAL USE, WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO CARTRIDGE BLOOD SET BLOOD TUBING SET FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. NA 01R158218

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R PHOENIX MACHINE, (B) (4), SW UNK| BICART 1250| BAXTER: CAHP210