BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 2823851 · Received October 10, 2012

    Report

    Report Number
    3004605321-2012-00017
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 10, 2010
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.A.R.
    Product Code
    HIF
    PMA / PMN Number
    K934131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE HOSPITAL REPORTED THAT DURING OPEN HEART SURGERY, THE INSUFFLATION TUBING WAS DEFECTIVE. DEROYAL: IT WAS CONCLUDED THAT THE RESIN USED TO MANUFACTURE THE INSUFFLATION TUBING WAS INCOMPATIBLE WITH HEART AND TIME VARIABLES THAT IT IS EXPOSED TO DURING SHIPMENT AND STERILIZATION. THIS CAUSES THE PLASTICIZER TO MIGRATE FROM THE TUBING TO THE FILTER HOUSING CAUSING OCCLUSION. MIGRATION RESISTANT MATERIAL, POLYCARBONATE, HAS BEEN CHOSEN AND SUCCESSFULLY TESTED FOR COMPATIBILITY OF EXPOSURE TO HIGH HEAT. IN (B)(4) 2008, A 100% INSPECTION OF THE MODIFIED DEVICE WAS PERFORMED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING OPEN HEART SURGERY THE INSUFFLATION TUBING WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL HIF- INSUFFLATOR, LAPAROSCOPIC HIF DEROYAL INTERCONTINENTAL, S.A.R. HEART TRACECART

    Patients

    Seq Age Sex Outcome Treatment
    1 Other