BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST TERUMO

    MDR report key: 15580293 · Received October 11, 2022

    Report

    Report Number
    1722028-2022-00331
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 10, 2022
    Manufacturer
    TERUMO BCT
    Product Code
    JQC
    UDI-DI
    05020583514225
    PMA / PMN Number
    K103340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FMF 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 B.5, H.6 AND H.10. ADDITIONAL PRODUCT CODE: FMF INVESTIGATION: A REVIEW OF THE CERTIFICATE OF COMPLIANCE SHOWS THAT THIS LOT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. AS THE REPORTED ADVERSE EVENT DID NOT RELATE TO ACTIVITIES ASSOCIATED WITH THE MANUFACTURE OF THIS LOT, FURTHER REVIEW OF THE DHR WAS NOT PERFORMED FOR THIS COMPLAINT RECORD. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND NO REPORTS FOR SIMILAR ISSUES ON THIS LOT. CORRECTION: THIS CUSTOMER WAS AWARE OF THE MISTAKE AND REPORTED THE ISSUE. HENCE, NO RETRAINING WAS REQUIRED. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THIS COMPLAINT. THE ROOT CAUSE WAS DETERMINED TO BE AN OPERATOR ERROR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: FMF INVESTIGATION: A REVIEW OF THE CERTIFICATE OF COMPLIANCE SHOWS THAT THIS LOT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. AS THE REPORTED ADVERSE EVENT DID NOT RELATE TO ACTIVITIES ASSOCIATED WITH THE MANUFACTURE OF THIS LOT, FURTHER REVIEW OF THE DHR WAS NOT PERFORMED FOR THIS COMPLAINT RECORD. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND NO REPORTS FOR SIMILAR ISSUES ON THIS LOT. CORRECTION: THIS CUSTOMER WAS AWARE OF THE MISTAKE AND REPORTED THE ISSUE. HENCE, NO RETRAINING WAS REQUIRED. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE USE OF AN EXPIRED HARVEST BMAC SET. PATIENT WEIGHT IS NOT AVAILABLE AT THIS TIME. THE DEVICE WAS USED FOR TREATMENT BUT NOT DIAGNOSIS. THE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE USE OF AN EXPIRED HARVEST BMAC SET. THE DEVICE WAS USED FOR TREATMENT BUT NOT DIAGNOSIS. CUSTOMER DID NOT PROVIDE PATIENT OUTCOME. THE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE USE OF AN EXPIRED HARVEST BMAC SET. THE DEVICE WAS USED FOR TREATMENT BUT NOT DIAGNOSIS. THE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482035 HARVEST TERUMO BONE MARROW ASPIRATE CONCENTRATE PROCEDURE PACK JQC TERUMO BCT 51422 11D9932 05020583514225

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other