BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 16034650 · Received December 22, 2022

    Report

    Report Number
    1722028-2022-00419
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    October 31, 2019
    Report Date
    December 22, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583102200
    PMA / PMN Number
    BK150251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: BOUGAR, S.,ATOUF, O.,OUADGHIRI, S.,BOURHANBOUR, A. D.,BRICK, C.,ESSAKALLI, M. COLLECTION, CRYOPRESERVATION AND THAWING OF STEM CELLS FOR CHILDREN WEIGHING LESS THAN 25 KG WITH HIGH-RISK NEUROBLASTOMA: A SINGLE CENTER RESULTS IN MOROCCO. HEMATOLOGY, TRANSFUSION, AND CELL THERAPY. 2022; 44(4): 535-541. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. LOT NUMBER AND EXPIRY ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: BOUGAR, S.,ATOUF, O.,OUADGHIRI, S.,BOURHANBOUR, A. D.,BRICK, C.,ESSAKALLI, M. COLLECTION, CRYOPRESERVATION AND THAWING OF STEM CELLS FOR CHILDREN WEIGHING LESS THAN 25 KG WITH HIGH-RISK NEUROBLASTOMA: A SINGLE CENTER RESULTS IN MOROCCO. HEMATOLOGY, TRANSFUSION, AND CELL THERAPY. 2022; 44(4): 535-541. FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR IS THERE A LIKELY POTENTIAL FOR DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. IT WAS CONFIRMED THAT THE AES IMPLICATED IN THIS ARTICLE ARE NOT-REPORTABLE EVENT. ONLY FOUR VASOVAGAL EFFECTS WERE RECORDED RELATED TO LEUKAPHERESIS, A MILD AND REVERSIBLE DECREASE IN BLOOD PRESSURE IN ONE CASE AT THE END OF THE PROCEDURE AND A PULSE RATE OVER 120 BPM, ONLY AT THE BEGINNING OF THE LEUKAPHERESIS.NEUROBLASTOMA. EMBRYONAL MALIGNANCY OF THE SYMPATHETIC NERVOUS SYSTEM. AUTOLOGOUS STEM CELL TRANSPLANTATION. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, 'COLLECTION, CRYOPRESERVATION AND THAWING OF STEM CELLS FOR CHILDREN WEIGHING LESS THAN 25 KG WITH HIGH-RISK NEUROBLASTOMA: A SINGLE CENTER RESULTS IN MOROCCO', DESCRIBES A SINGLE INSTITUTION¿S EXPERIENCE WITH CRYOPRESERVATION OF AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS (PBSCS), USING 10% DIMETHYL SULFOXIDE (DMSO) AND APPLYING POST-THAW DMSO DEPLETION. A TOTAL OF 36 APHERESES WERE PERFORMED ON 29 CHILDREN WEIGHING LESS THAN 25 KG BETWEEN JULY 2016 AND OCTOBER 2019. FOUR VASOVAGAL EFFECTS WERE RECORDED RELATED TO LEUKAPHERESIS, A MILD AND REVERSIBLE DECREASE IN BLOOD PRESSURE IN ONE CASE AT THE END OF THE PROCEDURE, AND A PULSE RATE OVER 120 BPM, ONLY AT THE BEGINNING OF THE LEUKAPHERESIS. PATIENT INFORMATION PROVIDED: SEVEN FEMALES AND TWENTY-TWO MALES, MEDIAN BODYWEIGHT 14 KG (9 - 22). INDIVIDUAL PATIENT INFORMATION WAS NOT AVAILABLE IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE LEUKAPHERESIS SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE, 'COLLECTION, CRYOPRESERVATION AND THAWING OF STEM CELLS FOR CHILDREN WEIGHING LESS THAN 25 KG WITH HIGH-RISK NEUROBLASTOMA: A SINGLE CENTER RESULTS IN MOROCCO', DESCRIBES A SINGLE INSTITUTION¿S EXPERIENCE WITH CRYOPRESERVATION OF AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS (PBSCS), USING 10% DIMETHYL SULFOXIDE (DMSO) AND APPLYING POST-THAW DMSO DEPLETION. A TOTAL OF 36 APHERESES WERE PERFORMED ON 29 CHILDREN WEIGHING LESS THAN 25 KG BETWEEN (B)(6) 2016 AND (B)(6) 2019. FOUR VASOVAGAL EFFECTS WERE RECORDED RELATED TO LEUKAPHERESIS, A MILD AND REVERSIBLE DECREASE IN BLOOD PRESSURE IN ONE CASE AT THE END OF THE PROCEDURE, AND A PULSE RATE OVER 120 BPM, ONLY AT THE BEGINNING OF THE LEUKAPHERESIS. PATIENT INFORMATION PROVIDED: SEVEN FEMALES AND TWENTY-TWO MALES, MEDIAN BODYWEIGHT 14 KG (9 - 22). INDIVIDUAL PATIENT INFORMATION WAS NOT AVAILABLE IN THE ARTICLE, THEREFORE THIS REPORT IS BEING SUBMITTED AS A SUMMARY OF EVENTS. THE LEUKAPHERESIS SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2918091 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET GKT TERUMO BCT 10220 05020583102200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other