BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARMEDA BIOMEDICUS CANNULA

    MDR report key: 6159145 · Received December 9, 2016

    Report

    Report Number
    2184009-2016-00033
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 12, 2016
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K884129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY ASSURANCE LABORATORY, VISUAL ANALYSIS CONFIRMED DAMAGE TO THE CANNULA BODY. CONCLUSION: AFTER INVESTIGATION AT MEDTRONIC, THE COMPLAINT OF DAMAGE/CRACK IN THE DEVICE WAS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ABNORMALITIES DURING MANUFACTURING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INVESTIGATION IDENTIFIED THE DAMAGE WAS CAUSED BY A FIBROUS MATERIAL THAT CREATED A DEEP GROOVE IN THE BODY OF THE CANNULA. THIS SUGGESTS THE DAMAGE/TEAR MAY HAVE BEEN THE RESULT OF A SUTURE TIED AROUND THE CANNULA. A REVIEW OF COMPLAINTS RECEIVED FOR THIS MODEL NUMBER SHOWED NO TRENDS FOR THIS OCCURRENCE OR SIMILAR CONFIRMED OCCURRENCES WARRANTING ESCALATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO RETURN TO MEDTRONIC FOR ANALYSIS BUT HAS NOT BEEN RECEIVED TO DATE. MEDTRONIC'S INVESTIGATION IS IN PROGRESS.

    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 THAT DURING A PROCEDURE, WHILE LIGATION TO THE ARTERIAL SUBCLAVIAN ARTERY WAS OCCURRING, THE CUSTOMER REPORTED THIS CANNULA BECAME COMPRESSED AND CRACKED JUST BELOW THE KNOTTING SUTURE. THE LIGATURE ON THE CANNULA WAS PLACED ON THE SLIM FRONT PART OF THE CANNULA BODY DIRECTLY BEHIND THE OUTFLOW HOLES. THE PATIENT SUFFERED BLOOD LOSS AS A RESULT OF THIS ISSUE, HOWEVER THE CUSTOMER INDICATED NO TRANSFUSIONS WERE REQUIRED TO ADDRESS THE BLOOD LOSS CAUSED BY THIS EVENT. THE PRODUCT WAS REPLACED WITH ANOTHER TO COMPLETE THE CASE. THE PRODUCT IS EXPECTED TO RETURN TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810364 CARMEDA BIOMEDICUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS CB96535-017 211655193

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR