BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSK III SYSTEM (3.8MM)

    MDR report key: 12707735 · Received October 27, 2021

    Report

    Report Number
    2242352-2021-00875
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 5, 2021
    Report Date
    February 8, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    UDI-DI
    00607567700314
    PMA / PMN Number
    K130382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4) CORRECTED SECTION: H3- IF OTHER PROVIDE CODE -EXPLAIN-"DEVICE DISCARDED". ANALYSIS OF PRODUCTION: (3331/213/67) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE MODE. HISTORICAL DATA ANALYSIS: (4109/213/67) THERE WAS 1 ADDITIONAL SIMILAR COMPLAINT REPORTED FOR THE REPORTED FAILURE MODE AND THE REPORTED LOT/SERIAL NUMBER. A REVIEW OF THE PRODUCT COMPLAINT TREND DATA WAS PERFORMED FOR THE MONTHS OF JUL 2021 THROUGH OCT 2021. THE REVIEW DOES NOT IDENTIFY AN INCREASING TREND OR AN ADVERSE TREND FOR THREE CONSECUTIVE MONTHS FOR THE PRODUCT FAMILY AND THE FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD NOV -2019 THROUGH OCT-2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. DEVICE DISCARDED: (4115/213/3221/67) DESPITE REQUEST AND/ OR CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED; HOWEVER, THE ACTUAL DEVICE INVOLVED IN THE ADVERSE EVENT HAD BEEN ALREADY DISCARDED AND THUS IRRETRIEVABLY LOST FOR TESTING COMMUNICATION/INTERVIEWS: (4111/213/67) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. H3 OTHER TEXT : DEVICE DISCARDED.

    Description of Event or Problem · 0

    RELATED TO (B)(4).

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    RELATED TO (B)(4) (SAME PATIENT). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HST III SYSTEM (3.8MM) WOULD NOT DEPLOY PROPERLY. FINISHED CASE WITH ANOTHER HEARTSTRING. NO PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600393 HSK III SYSTEM (3.8MM) CLAMP, VASCULAR DXC MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) 25159298 00607567700314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown