BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1971421 · Received January 13, 2011

    Report

    Report Number
    8030638-2011-00002
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 14, 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 BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS DISCARDED BY THE FACILITY AND WILL NOT BE AVAILABLE FOR INVESTIGATION. RETAINED BLOOD TUBING SAMPLES FROM THE SAME LOT NUMBER REPORTED 10R158206 WERE VISUALLY INSPECTED, FUNCTIONAL AND DIMENSIONAL TESTING PERFORMED WITH NO FAILURES DETECTED.

    Description of Event or Problem · 1

    APPROX TWO HOURS AND FIFTY-FIVE MINUTES INTO TREATMENT, THE PT FELT NAUSEATED, WARM, DIAPHORETIC AND HER BLOOD PRESSURE WAS DECREASED TO 113/98 MMHG. OXYGEN WAS STARTED AT 2 LMP, VIA NASAL CANNULA. THE TREATMENT WAS TERMINATED 18 MINUTES EARLY, AND THE EXTRACORPOREAL CIRCUIT WAS RINSED BACK WITH 340 ML OF SALINE. THE PATIENT'S BLOOD PRESSURE WAS 189/132 MMGH AFTER RINSE BACK AND SHE COMPLAINED OF LOWER RIGHT ABDOMINAL PAIN AND CRAMPS IN HER FEET. DURING THE TREATMENT THE BLOOD IN THE DIALYZER APPEARED NORMAL IN COLOR, AND NO MACHINE ALARMS WERE DOCUMENTED. THERE HAD BEEN NO PROBLEMS IN INITIATING TREATMENT. THE NURSE DID NOT RECALL OBSERVING ANY KINKS IN THE LINES OR ANY UNUSUAL TUBING MOVEMENT OR NOISES FROM THE CIRCUIT DURING THE TREATMENT. FOUR HOURS LATER, THE PT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF ACCELERATED HYPERTENSION, HYPERCALCEMIA AND POSSIBLE HEMOLYTIC ANEMIA. THE PATIENT'S HEMOGLOBIN AND HEMATOCRIT REMAINED STABLE AND SHE DID NOT RECEIVE ANY BLOOD PRODUCTS. THE BAXTER DIALYZER, GAMBRO BLOOD TUBING SET, AND GAMBRO BICART 1250 WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN TO GAMBRO. THE CLINICAL INFO PROVIDED IS INDICATIVE OF HEMOLYSIS SECONDARY TO AUTOIMMUNE HEMOLYTIC ANEMIA, POSSIBLY RELATED TO THE PATIENT'S DIAGNOSIS OF SYSTEMIC LUPUS ERYTHEMATOSUS. THE PT DID NOT RECEIVE ANY ANTICOAGULANT IN CONJUNCTION WITH THE DIALYSIS TREATMENT SECONDARY TO A PREVIOUS DIAGNOSIS OF HIT. THE PHOENIX MACHINE WAS INSPECTED BY A GAMBRO SERVICE TECHNICIAN AND FOUND TO BE OPERATING WITHIN MANUFACTURER SPECIFICATIONS.

    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 10R158206

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R PHOENIX: SN (B)(4) 3.36 0HA| BAXTER XENIUM XPH210: LOT NUMBER 10H263| BICART 1250: LOT NUMBER 05478