BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE

    MDR report key: 5075021 · Received September 11, 2015

    Report

    Report Number
    1718850-2015-00356
    Event Type
    Other
    Date Received
    September 11, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    K972503
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING CARDIOPLEGIA DELIVERY THERE WAS NO FLUID COMING OUT THE CARDIOPLEGIA TUBING. THE CLINICAL SPECIALIST NOTED THAT WHERE THE LUER CONNECTS TO THE TUBING, IT APPEARED BLOCKED. THERE WAS NO REPORT OF PATIENT INJURY. THE INVOLVED CARDIOPLEGIA WYE LINE WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. A VISUAL INSPECTION OF THE LINE CONFIRMED THAT THE FEMALE LUER WAS COMPLETELY OCCLUDED WITH THE ADHESIVE USED FOR BONDING. NO OTHER DEFECTS OR ABNORMALITIES WERE FOUND. THERE IS NO REMAINING INVENTORY OF THIS LOT NUMBER. THE REPORTED ISSUE WAS CAUSED BY A MANUFACTURING ERROR. THE INDIVIDUALS RESPONSIBLE FOR ASSEMBLING AND INSPECTING THIS LINE WERE GATHERED TOGETHER, THE MANUFACTURING OPERATING PROCEDURE WAS REVIEWED, AND THE POSSIBLE CAUSES FOR THIS OCCLUSION WERE DISCUSSED TO ENSURE THAT THE PROPER STEPS NEEDED FOR THIS BUILD WERE CLEARLY UNDERSTOOD. SORIN GROUP USA HAS DETERMINED THAT A CAPA IS NOT NEEDED. THERE WAS NO PATIENT INJURY, NO TREND HAS BEEN IDENTIFIED AND A CORRECTION HAS BEEN PERFORMED. SORIN GROUP WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT PROVIDED. SORIN GROUP RECEIVED A REPORT THAT DURING CARDIOPLEGIA DELIVERY THERE WAS NO FLUID COMING OUT THE CARDIOPLEGIA TUBING. THE CLINICAL SPECIALIST NOTED THAT WHERE THE LUER CONNECTS TO THE TUBING, IT APPEARED BLOCKED. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING CARDIOPLEGIA DELIVERY THERE WAS NO FLUID COMING OUT THE CARDIOPLEGIA TUBING. THE CLINICAL SPECIALIST NOTED THAT WHERE THE LUER CONNECTS TO THE TUBING, IT APPEARED BLOCKED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601367 CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC. NA 1507900104

    Patients

    Seq Age Sex Outcome Treatment
    1 NP