BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 20810736 · Received November 29, 2024

    Report

    Report Number
    6000033-2024-00048
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    November 7, 2024
    Report Date
    February 5, 2025
    Manufacturer
    CARDIAC SURGERY MFG KERKRADE
    Product Code
    DWE
    PMA / PMN Number
    K171979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS THE NEGATIVE UMBRELLA VALVE OUT OF POSITION. THE DEVICE HAS THE TEST MARK. FUNCTIONAL TESTING WAS PERFORMED FROM 0 TO 0.5 LPM, THERE WAS LEAKING OBSERVED FROM THE NEGATIVE UMBRELLA VALVE. REASON FOR RETURN WAS CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    G.2.3. THE CORRECT AWARE DATE FOR 6000033-2024-00048 IS 24TH JAN 2025. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CIRCUIT WAS SET UP WITH NO ISSUES AND NO ISSUES WERE NOTED WITH THE CIRCUIT COMPONENTRY. UPON PRIMING THE CARDIOPLEGIA CIRCUIT, A LOT OF FLUID WAS POURING OUT OF ONE SIDE OF THE PRESSURE RELIEF VALVE. UPON LOOKING AT THE PRESSURE RELIEF VALVE THAT WAS THOUGHT TO BE FAULTY, IT APPEARED LIKE THERE WAS A DIFFERENCE IN THE STRUCTURE OF THE FLUID RELEASE PART OF THE VALVE. SEE ATTACHED PHOTO. THE LINE WAS CHANGED OUT AND THE CIRCUIT WAS USED WITHOUT ANY INCIDENT TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SAME LEAK APPEARED IN ANOTHER MULTIPLE PACK. THERE WAS NO VISIBLE AIR IN SYSTEM/TUBING. THE EXACT LOCATION OF THE LEAK IN THE CUSTOM TUBING PACK SPECIFICATION WAS ON PAGE 2, LINE 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439833 CUSTOM TUBING PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE CARDIAC SURGERY MFG KERKRADE M610804W 229280284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown