BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER

    MDR report key: 5546226 · Received April 4, 2016

    Report

    Report Number
    1718850-2016-00220
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    November 27, 2015
    Report Date
    December 4, 2015
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    K981601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE HEART COULD NOT BE DRAINED DURING A PROCEDURE BECAUSE THE MALLEABLE VENT CATHETER WAS BLOCKED. THERE WAS NO REPORT OF PATIENT INJURY. ON (B)(6) 2015, THIS ISSUE WAS REPORTED BY THE CUSTOMER TO THE LOCAL COMPETENT AUTHORITY WHERE THE EVENT OCCURRED. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. THE COMPLAINT PRODUCT WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. PHOTOGRAPHIC AND VISUAL INSPECTION CONFIRMED OCCLUSION ON THE PROXIMAL END OF THE CANNULA AT THE CONNECTOR BOND. THE UNIT APPEARS TO BE COMPLETELY OCCLUDED DUE TO EXCESSIVE ADHESIVE. THIS OCCLUSION WAS CAUSED BY A MANUFACTURING ERROR. ALL INDIVIDUALS RESPONSIBLE FOR ADHESION APPLICATION AND INSPECTION OF THE PRODUCT BEFORE RELEASE WERE GATHERED TOGETHER BASED ON THE REPORTED LOT NUMBER. THE MANUFACTURING OPERATING PROCEDURE ADDRESSING UV ADHESIVE APPLICATION AND CURING METHODS WERE REVIEWED, AND THE POSSIBLE CAUSES FOR THIS CONCERN WERE DISCUSSED TO ENSURE THAT THE PROPER STEPS NEEDED FOR THIS ASSEMBLY WERE CLEARLY UNDERSTOOD. IF AN OCCLUSION OF THIS NATURE WERE TO REOCCUR, IT WOULD BE FOUND DURING THE PRIMING OF FLUSHING OF THE PRODUCE BEFORE USED, AS INSTRUCTED IN THE INSTRUCTIONS FOR USE. THE MEDICAL STAFF WOULD BE ABLE TO EXCHANGE THE DEVICE FOR ANOTHER.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP RECEIVED A REPORT THAT THE HEART COULD NOT BE DRAINED DURING A PROCEDURE BECAUSE THE MALLEABLE VENT CATHETER WAS BLOCKED. THERE WAS NO REPORT OF PATIENT INJURY. ON (B)(6) 2015, THIS ISSUE WAS REPORTED BY THE CUSTOMER TO THE LOCAL COMPETENT AUTHORITY WHERE THE EVENT OCCURRED. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION IS IN PROGRESS.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE HEART COULD NOT BE DRAINED DURING A PROCEDURE BECAUSE THE MALLEABLE VENT CATHETER WAS BLOCKED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200889 CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC. 1512500048

    Patients

    Seq Age Sex Outcome Treatment
    1