BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 5536794 · Received March 30, 2016

    Report

    Report Number
    2242352-2016-00311
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    February 9, 2016
    Report Date
    February 12, 2016
    Manufacturer
    MAQUET CV
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25119168, 25121718, 25121538 AND 25122284 ARE THE LAST (B)(4) LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY

    Additional Manufacturer Narrative · 1

    ON 03/30/2016 02:48 PM (GMT-4:00) ADDED BY (B)(6): 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. (B)(4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYSTEM 3.8MM DID NOT DEPLOY. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. DID NOT DEPLOY.

    Description of Event or Problem · 1

    ON 03/28/2016 06:58 PM (GMT-4:00) ADDED BY (B)(6): THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYSTEM 3.8MM DID NOT DEPLOY. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. ON 03/25/2016 01:10 PM (GMT-4:00) ADDED BY (B)(6): DID NOT DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192065 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR DXC MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1