BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EOPA ARTERIAL CANNULA

    MDR report key: 3870949 · Received June 12, 2014

    Report

    Report Number
    2184009-2014-00041
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 18, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K031037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE CANNULA WAS NOT PROVIDED BY THE USER FACILITY, SO A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. MEDTRONIC HAS INITIATED A FORMAL INVESTIGATION INTO THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE TO MEDTRONIC FOR ANALYSIS, BUT THE REPORTED DAMAGE TO THE CANNULA WAS CONFIRMED THROUGH A PHOTOGRAPH PROVIDED BY THE CUSTOMER. BASED ON THE PHOTOGRAPH AND THE STATEMENT FROM THE CUSTOMER, THE SPLIT WAS IN THE OUTER LUMEN BUT DID NOT AFFECT THE INTEGRITY OF THE INNER LUMEN, AND NO LEAKS WERE OBSERVED. THE PHOTOGRAPH OF THE CANNULA WAS FORWARDED TO THE CONTRACT MANUFACTURER FOR ADDITIONAL ANALYSIS AND INVESTIGATION OF ROOT CAUSE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE CASE, THIS 77620 CANNULA CRACKED WHERE IT WAS SUTURED TO THE PATIENT'S SKIN. THE DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WILL NOT BE RETURNED, REASON NOT GIVEN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE CASE, THE OUTER LUMEN OF THIS 77620 CANNULA CRACKED WHERE IT WAS SUTURED TO THE PATIENT'S SKIN. THERE WERE NO LEAKS REPORTED, AND THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE ISSUE. THE CUSTOMER INDICATED THAT THE PRODUCT WOULD NOT BE RETURNED FOR ANALYSIS, BUT A PHOTOGRAPH OF THE CANNULA WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347491 EOPA ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 77620 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1