BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 1890095 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00048
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    June 8, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K071079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EQUIPMENT WAS CHECKED OUT THROUGH AUTO-TEST AND A SIMULATED RUN WITH NO PROBLEMS FOUND. FURTHER THE SERVICE REP LEARNED THAT FURTHER RUNS WERE PERFORMED ON THE EQUIPMENT WITH NO ISSUES REPORTED. STERILIZATION RECORDS FOR LOT 03S3331 WERE REVIEWED AND FOUND NO EXCEPTIONS IN STERILIZATION FOR THIS LOT. ACCORDING TO THE DOCTOR MONITORING THE SITE, DOUGLAS KENNY, SCIENTIFIC EXPERT, JERRY BILL FROM CARIDIANBCT, THE PT HAD MULTIPLE UNDERLYING PHYSIOLOGICAL CAUSES FOR THE REACTIONS. HE HAD ONE VERY DEFINITE UNDERLYING REASONS TO BE UNUSUALLY PRONE TO HYPOCALCAEMIC SYMPTOMS, NAMELY PRE-EXISTING HYPOMAGNESEMIA, A RECOGNIZED PROBLEM WITH DHAP CHEMOTHERAPY. HE ALSO HAD TWO OTHER UNCONNECTED PROBLEMS THAT MIGHT HAVE MADE HIM MORE PRONE TO TETANY, NAMELY HE WAS ANEMIC WITH HB OF JUST 7.8G/SL AND HE WAS MOST LIKELY INFECTIOUS (PYREXIA) AS DEMONSTRATED BY A SPIKING TEMPERATURE SHORTLY POST-PROCEDURE. ADMISSION TO THE HOSPITAL WAS BASED ON THIS PYREXIA, FOR ANTIBIOTIC THERAPY. PT WAS MUCH BETTER (B)(6). AFTER IV MAGNESIUM SULPHATE, BLOOD TRANSFUSION AND IV ANTIBIOTICS OVERNIGHT, THOUGH STILL RUNNING A LOW-GRADE, BORDERLINE PYREXIA WITH NO LOCALIZING SIGNS OR SYMPTOMS. SECOND PBSC COLLECTION, AND HE GOT A GOOD CELL DOSE. HE HAD IV CALCIUM GLUCONATE AND ORAL DIAZEPAM PRIOR TO THE PROCEDURE, AND HAD NO CITRATE ISSUES. HE WAS DISCHARGED HOME ON ORAL ANTIBIOTICS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. SOURCE: DURING VALIDATION TRIALS OF MNC SOFTWARE ON OPTIA A (B)(6) GENTLEMAN, WITH RELAPSED HODGKIN LYMPHOMA WAS UNDERGOING A PBSC COLLECTION USING HIS THIRD CYCLE OF DHAP CHEMO (LYMPHOMA, SALVAGE CHEMO REGIME) AS MOBILIZING CHEMOTHERAPY. ABOUT 60% OF THE WAY THROUGH AN OPTIA WBC PROCEDURE, HE DEVELOPED HYPOCALCAEMIC SYMPTOMS (TINGLING AND NAUSEA), RAPIDLY PROGRESSING TO FRANK HYPOCALCAEMIC TETANY WITH MUSCLE SPASMS IN HIS HANDS, FOREARMS AND CALVES. THE PROCEDURE WAS PAUSED AND THEN STOPPED (PERFORMING RINSEBACK) AS HIS SYMPTOMS DID NOT RESOLVE FULLY AFTER TWO DOSES OF 2.24 MMOL IV CALCIUM GLUCONATE. IT WAS THEN DISCOVERED THAT HIS MAGNESIUM HAD BEEN VERY LOW AT 0.44 MMOL/L PRE-PROCEDURE: THIS HAS PROBABLY BEEN THE MAIN UNDERLYING CAUSE OF HIS TETANY. TO COMPLICATE THINGS FURTHER, HE THEN SPIKED A PYREXIA/FEVER OF 38.9 OC, WHICH REQUIRED HOSPITAL ADMISSION FOR ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 03S3331

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R