BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 10038943 · Received May 8, 2020

    Report

    Report Number
    1722028-2020-00218
    Event Type
    Injury
    Date Received
    May 8, 2020
    Date of Event
    January 1, 2016
    Report Date
    May 8, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5, H.6 AND H.10. INVESTIGATION: ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF (B)(4). SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. TRANSIENT HYPOCALCEMIA ASSOCIATED WITH APHERESIS IS USUALLY WELL TOLERATED. SYMPTOMS OFTEN SHOW AS PARESTHESIA (TINGLING) BUT PATIENTS MAY ALSO EXPERIENCE UNUSUAL TASTE, NAUSEA, LIGHTHEADEDNESS, SHIVERING, AND TREMORS. SEVERE HYPOCALCEMIA MAY ALSO CAUSE MUSCLE CONTRACTIONS AND CAN PROGRESS TO TETANY AND SEIZURES IF HYPOCALCEMIA ESCALATES AND IS NOT CORRECTED. SINCE THIS WAS A RETROSPECTIVE STUDY TO EVALUATE 40 PATIENTS WITH AN AGE RANGE OF 3-15 YEARS ADMITTED TO A TERTIARY CARE TEACHING HOSPITAL, FROM (B)(6) 2013 TO (B)(6) 2014, REFERRED FOR TPE, THE LOT NUMBERS ARE UNKNOWN; THEREFORE, DHR SEARCHES COULD NOT BE CONDUCTED FOR THE REPORTED INCIDENTS. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR PATIENT REACTIONS COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THE ALLEGED HYPOTENSION INCLUDE BUT ARE NOT LIMITED TO PATIENT DISEASE STATE, PATIENT SENSITIVITY TO THE PROCEDURE, THE LENGTH OF THE PROCEDURE, AND/OR THE HEMODYNAMIC STRESS OF THE PROCEDURE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED CITRATE REACTIONS COULD NOT BE DETERMINED. THESE REACTIONS OCCUR DUE TO DECREASED IONIZED CALCIUM IN CIRCULATION AS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY PATIENT PHYSIOLOGY, THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE CITRATE CONTENTS IN THE REPLACEMENT FLUID, AND/OR THE LENGTH OF THE PROCEDURE. THESE SYMPTOMS MAY BE TREATED WITH ORAL OR INTRAVENOUS CALCIUM SUPPLEMENTS OR BY ADJUSTING THE AC INFUSION RATE. ROOT CAUSE FOR INADEQUATE VASCULAR ACCESS WAS DUE TO INADEQUATE FLUSHING OF THE CATHETER BY SALINE AND HEPARIN AT REGULAR INTERVALS IF UNUSED. CAUSE FOR THE REPORTED MACHINE ERROR IS UNKNOWN BUT MAY BE RELATED TO: - OPERATOR LOADING ERROR - AN ISSUE WITH THE OPTIA DEVICE.

    Description of Event or Problem · 0

    PER THE ARTICLE, CALCIUM GLUCONATE INFUSION (10 ML OF CALCIUM GLUCONATE IN 500 ML NORMAL SALINE [NS]) WAS GIVEN DURING THE PROCEDURE TO PREVENT CITRATE TOXICITY. THIS WAS A RETROSPECTIVE STUDY TO EVALUATE 40 PATIENTS, BOTH MALE AND FEMALE, WITH AN AGE RANGE OF 3-15 YEARS ADMITTED TO A (B)(6) HOSPITAL, FROM (B)(6) 2013 TO (B)(6) 2014, REFERRED FOR TPE. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: COMPLICATIONS WERE OBSERVED IN 14 PATIENTS WHO WERE WELL MANAGED: INADEQUATE VASCULAR ACCESS WAS MOST COMMON COMPLICATION OBSERVED IN 11 PATIENTS DUE TO INADEQUATE FLUSHING OF THE CATHETER BY SALINE AND HEPARIN AT REGULAR INTERVALS IF UNUSED. THERE WAS ONE REPORTED MACHINE ERROR WAS OF CENTRIFUGATION DURING THE PROCEDURE, AND IT LED TO THE ABORTION OF PROCEDURE. ARTICLE CITATION: GAJJAR, M, ET AL. 2016. THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS OF GUILLAIN¿BARRE SYNDROME: EXPERIENCE FROM A TERTIARY CARE CENTRE. ASIAN JOURNAL OF TRANSFUSION SCIENCE. 2016 JAN-JUN; 10(1): 98¿100. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE ARTICLE, 'THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC PATIENTS OF GUILLAIN¿BARRE SYNDROME: EXPERIENCE FROM A TERTIARY CARE CENTRE' (GAJJAR 2016) DESCRIBES 40 PEDIATRIC PATIENTS WHO UNDERWENT 122 THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURES FOR TREATMENT OF GUILLAN-BARRE SYNDROME (GBS). ALL PATIENTS WERE TREATED WITH SPECTRA OPTIA. MORE THAN THREE TPE PROCEDURES WERE PERFORMED IN 29 PATIENTS, OF WHICH 27 PATIENTS SHOWED IMPROVEMENT FROM GRADE-0 AND GRADE-I TO GRADE-III. PATIENTS WERE BETWEEN 3 TO 15 YEARS OF AGE. TPE PROCEDURES WERE PERFORMED ON ALTERNATE DAYS DEPENDING ON THE CLINICAL CONDITION OF THE PATIENT. PATIENT'S TOTAL BLOOD VOLUME WAS CALCULATED AS PER NADLER'S FORMULA AND PROCESSED THROUGH CENTRAL DOUBLE LUMEN CATHETER. 1-1.5 PLASMA VOLUME WAS EXCHANGED WITH NORMAL SALINE AND FRESH FROZEN PLASMA. THERE WERE TWO REPORTED PATIENT REACTION EVENTS (1 OCCURRENCE OF SHIVERING AND 1 OCCURRENCE OF HYPOTENSION) FOR WHICH MEDICAL INTERVENTION WAS UNCLEAR. SPECIFIC DETAILS REGARDING PATIENT INFORMATION WAS NOT INCLUDED IN THIS ARTICLE, THEREFORE, THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN BECAUSE THEY WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501965 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other