BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST TERUMO

    MDR report key: 7053058 · Received November 22, 2017

    Report

    Report Number
    1722028-2017-00453
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 22, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    JQC
    PMA / PMN Number
    K103340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN. HARVEST PRODUCT SETS CONTAIN MULTIPLE COMPONENTS THAT HAVE VARIOUS EXPIRY DATES. THE OUTER SET LABEL CONTAINS THE EXPIRY DATE ASSOCIATED WITH THE COMPONENT THAT HAS THE SHORTEST EXPIRY TIMEFRAME. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. TERUMO BCT HAS FOLLOWED UP WITH THIS CUSTOMER TO PROVIDE FEEDBACK ON THE REPORTED CONDITION. ROOT CAUSE: ROOT CAUSE WAS DETERMINED TO BE A USER ERROR WHERE THE CUSTOMER INADVERTENTLY USED AN EXPIRED SET. THE OUTER KIT LABEL CONTAINS THE EXPIRY DATE ASSOCIATED WITH THE COMPONENT THAT HAS THE SHORTEST EXPIRY TIMEFRAME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: FMF. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE PATIENT WEIGHT AND OUTCOME.

    Description of Event or Problem · 1

    UPON REVIEW OF THE INFORMATION PROVIDED BY THE DISTRIBUTOR, IT WAS DISCOVERED THAT AN EXPIRED BONE MARROW ASPIRATE CONCENTRATE (BMAC) DISPOSABLE WAS USED ON A PATIENT. THE BMAC DISPOSABLE SET WAS LABELED WITH AN EXPIRATION DATE OF 10/01/2017. THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. PATIENT WEIGHT IS NOT AVAILABLE AT THIS TIME. PATIENT OUTCOME IS NOT AVAILABLE AT THIS TIME. THE BMAC DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834217 HARVEST TERUMO BMAC2 60-01, BONE MARROW ASPIRATE CONCENTRATE PROCEDUR JQC TERUMO BCT 11Z9950

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other