BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 17768883 · Received September 18, 2023

    Report

    Report Number
    1722028-2023-00307
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 18, 2023
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    UDI-DI
    05020583123205
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: BRAY K, LYNDE C, VU T, ET AL. PREVALENCE OF BASELINE HYPOCALCEMIA AND SYMPTOMATIC HYPOCALCEMIA DURING LEUKAPHERESIS. J CLIN APHER. 2023;1-10. DOI:10.1002/JCA.22076.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. 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. THE INTENT OF THE STUDY WAS TOO DETERMINE THE PREVALENCE OF BASELINE HYPOCALCEMIA AND CA SUPPLEMENTATION WAS PREPLANNED PER THE STUDY. THEREFORE, NO UNINTENDED MEDICAL INTERVENTION OCCURRED. NO FURTHER REPORTING WILL BE PROVIDED AS THIS DOES NOT REPRESENT A REPORTABLE EVENT.  CITATION: BRAY K, LYNDE C, VU T, ET AL. PREVALENCE OF BASELINE HYPOCALCEMIA AND SYMPTOMATIC HYPOCALCEMIA DURING LEUKAPHERESIS. J CLIN APHER. 2023;1-10. DOI:10.1002/JCA.22076.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "PREVALENCE OF BASELINE HYPOCALCEMIA AND SYMPTOMATIC HYPOCALCEMIA DURING LEUKAPHERESIS" BY BRAY ET AL. SYMPTOMS OF HYPOCALCEMIA ARE REPORTED IN UP TO 50% OF PATIENTS UNDERGOING LEUKAPHERESIS PROCEDURES. THERE IS NO SET STANDARD OF PRACTICE FOR ADMINISTERING CALCIUM SUPPLEMENTATION IN THE PREVENTION OR TREATMENT OF HYPOCALCEMIA SYMPTOMS. THE GOAL OF THIS DESCRIPTIVE, RETROSPECTIVE STUDY WAS TO DETERMINE THE PREVALENCE OF BASELINE HYPOCALCEMIA AND SYMPTOMATIC HYPOCALCEMIA DURING LEUKAPHERESIS WITH ACID CITRATE DEXTROSE SOLUTION A AND TO IDENTIFY PATIENT CHARACTERISTICS ASSOCIATED WITH SYMPTOMATIC HYPOCALCEMIA. THREE PERCENT OF PATIENTS WERE FOUND TO HAVE HYPOCALCEMIA BEFORE LEUKAPHERESIS WITH 35% EXPERIENCING HYPOCALCEMIA SYMPTOMS DURING LEUKAPHERESIS. OLDER AGE, HIGHER ALBUMIN LEVELS, AND LONGER PROCEDURE TIME WERE ASSOCIATED WITH INCREASED RISK OF HYPOCALCEMIA SYMPTOMS MEDICAL INTERVENTION IN THE FORM OF PROPHYLACTIC CALCIUM SUPPLEMENTATION ADMINISTERED THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE "PREVALENCE OF BASELINE HYPOCALCEMIA AND SYMPTOMATIC HYPOCALCEMIA DURING LEUKAPHERESIS" BY BRAY ET AL. SYMPTOMS OF HYPOCALCEMIA ARE REPORTED IN UP TO 50% OF PATIENTS UNDERGOING LEUKAPHERESIS PROCEDURES. THERE IS NO SET STANDARD OF PRACTICE FOR ADMINISTERING CALCIUM SUPPLEMENTATION IN THE PREVENTION OR TREATMENT OF HYPOCALCEMIA SYMPTOMS. THE GOAL OF THIS DESCRIPTIVE, RETROSPECTIVE STUDY WAS TO DETERMINE THE PREVALENCE OF BASELINE HYPOCALCEMIA AND SYMPTOMATIC HYPOCALCEMIA DURING LEUKAPHERESIS WITH ACID CITRATE DEXTROSE SOLUTION A AND TO IDENTIFY PATIENT CHARACTERISTICS ASSOCIATED WITH SYMPTOMATIC HYPOCALCEMIA. THREE PERCENT OF PATIENTS WERE FOUND TO HAVE HYPOCALCEMIA BEFORE LEUKAPHERESIS WITH 35% EXPERIENCING HYPOCALCEMIA SYMPTOMS DURING LEUKAPHERESIS. OLDER AGE, HIGHER ALBUMIN LEVELS, AND LONGER PROCEDURE TIME WERE ASSOCIATED WITH INCREASED RISK OF HYPOCALCEMIA SYMPTOMS MEDICAL INTERVENTION IN THE FORM OF PROPHYLACTIC CALCIUM SUPPLEMENTATION ADMINISTERED THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902856 SPECTRA OPTIA SPECTRA OPTIA IDL SET LKN TERUMO BCT 05020583123205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other