BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC PERFUSION CANNULAE

    MDR report key: 9295918 · Received November 8, 2019

    Report

    Report Number
    3008500478-2019-00167
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 17, 2019
    Report Date
    October 17, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K123370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3. PRODUCT EVALUATION: CUSTOMER COMPLAINT THAT "THE BOTTOM OF PACKAGE OF THE EZ-GLIDE CANNULA WAS NOT SEALED " WAS CONFIRMED THROUGH IMAGE EVALUATION. IN THE POUCH PACKAGING PHOTOS PROVIDED, ONE END APPEARED UNSEALED AND THE OTHER END APPEARED OPENED. CANNULA POUCH PACKAGING WAS NOT RETURNED WITH CANNULA. DEVICE WAS RETURNED WITH VISIBLE TRACES OF BLOOD AND WAS EXAMINED IN THE BIOHAZARD AREA OF LAB. NO OTHER VISIBLE DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES WERE OBSERVED FROM RETURNED DEVICE. PHOTOS ATTACHED BY COMPLAINT HANDLER APPEARED INCONSISTENT WITH LAB FINDINGS; POUCH PACKAGING WAS NOT RETURNED. H10. ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS D4 (EXPIRATION DATE), H3, H4, AND H6. MANUFACTURING RECORDS WERE REVIEWED AND NO NON-CONFORMITIES WERE RECORDED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. NO MANUFACTURING DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: SUPPLIER MANUFACTURING DEFECT WAS CONFIRMED THROUGH IMAGE EVALUATION. DESIGN, LABELING, AND IFU DEFECTS WERE NOT CONFIRMED. TREND IS IN CONTROL. FMEA LINE ITEM IS APPROPRIATE. CAPA ACTION IS REQUIRED. PRA ACTION IS NOT REQUIRED. THE ROOT CAUSE OF THIS EVENT IS SUPPLIER MANUFACTURING.

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA: UPDATED SECTION H6. MANUFACTURING, SUPPLIER, DESIGN, IFU, AND LABELING DEFECTS WERE NOT CONFIRMED. TREND IS IN CONTROL. FMEA LINE ITEM IS APPROPRIATE. CAPA ACTION IS REQUIRED. PRA ACTION IS NOT REQUIRED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. EVALUATION IS IN PROGRESS. ANY PACKAGING NON-CONFORMANCE THAT RESULTS IN A BREACH OF THE STERILE PACKAGE (I.E. PINHOLE, TEAR OR SEAL ISSUE), HAS THE POTENTIAL TO RESULT IN A SERIOUS INFECTION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM OF PACKAGE OF AN AORTIC PERFUSION CANNULA WAS NOT SEALED WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED FOR THE PATIENT AND REPLACED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088597 AORTIC PERFUSION CANNULAE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EZF24A 218185

    Patients

    Seq Age Sex Outcome Treatment
    1