BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60/60/90 MULTIPAK-OPTISTAR LE X50

    MDR report key: 11132268 · Received January 7, 2021

    Report

    Report Number
    3012395857-2020-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    December 4, 2020
    Manufacturer
    SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD
    Product Code
    DXT
    PMA / PMN Number
    K151960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OVERALL INVESTIGATION SUMMARY: INVESTIGATION HAS BEEN DONE AT BOON SITE. ISSUE REPORTED: THE FACILITY IS EXPERIENCING CONTRAST "WAS OUT"DURING MRA PROCEDURES. THE CONTRAST IS MIXING WITH THE SALINE PRIOR TO THE INJECTION. BOON HAS RECEIVED 4 COMPLAINTS FOR TUBING- CHECK VALVE ISSUES SINCE (B)(6) 2019 ACCOUNTING FOR (B)(4) OF THE TOTAL CUSTOMER COMPLAINTS. ROOT / PROBABLE CAUSE CODE. ROOT / PROBABLE CAUSE SUMMARY: THERE IS NO ROOT CAUSE, THE PRODUCT IS WORKING ACCORDING TO BOON SPECIFICATIONS AND CUSTOMER SPECIFICATIONS. THIS IS NOT A QUALITY ISSUE. DISPOSITION SUMMARY: WE SUGGEST THAT THE CUSTOMER CHANGES THE Y-TUBING TO CONTAIN 2 CHECK VALVES AS OPPOSED TO ONLY ONE. NO ACTION PLAN WILL BE TAKEN.

    Description of Event or Problem · 1

    THE INCIDENTS WERE REPORTED BY A FACILITY IN (B)(4) ON (B)(6) 2020. REPORTER STATES THAT THIS SITE RECENTLY SWITCHED FROM MR DUAL SYRINGE PACK # 801800 TO 801800B AND THEY ARE NOW EXPERIENCING WASH OUT AFTER ALL THEIR MRA EXAMS. THE SITE BELIEVES WITH THE NEW SYRINGE PACK THAT SOMEHOW THE CONTRAST AND SALINE ARE MIXING PRIOR TO THE INJECTION. THEY BELIEVE WITH THE HIGHER FLOW RATES THE CONTRAST IS BEING PUSHED INTO THE SALINE SYRINGE CAUSING DILUTED CONTRAST IMAGING. THIS HAS OCCURRED IN APPROX 8 EXAMS. THE PATIENTS ARE CONNECTED WHEN THE ISSUES OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25524 60/60/90 MULTIPAK-OPTISTAR LE X50 60/60/90 MULTIPAK-OPTISTAR LE X50 DXT SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD 801800B

    Patients

    Seq Age Sex Outcome Treatment
    1