BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 22902160 · Received August 27, 2025

    Report

    Report Number
    9617601-2025-01179
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 27, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    DWF
    UDI-DI
    00763000371456
    PMA / PMN Number
    K171979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWED THE RETURNED TUBING TO BE UNIFORM IN SIZE, APPROXIMATELY 3/8 INCHES. THE SPECIFICATION HAS THE TUBING TO BE TAPERED WITH THE SECTION BETWEEN THE WHITE TAPE TO BE 1/2 INCH IN DIAMETER. A SECTION OF THE TUBING BETWEEN THE WHITE TAPE MARKS WAS CUT OUT AND THE INNER DIAMETER WAS MEASURED USING A KEYENCE SCOPE TO BE 0.361 INCHES. THE REASON FOR THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE CUSTOM TUBING PACK, THE ARTERIAL BOOT WAS IDENTIFIED AS A STRAIGHT 3/8" TUBING INSTEAD OF THE REQUIRED 3/8" BY 1/2" TAPERED BOOT. LOW FLOW WAS OBSERVED. THE RPMS WERE INCREASED. A FLOW PROBE WAS ATTACHED TO THE LINE AND RPMS INCREASED TO AN APPROPRIATE FLOW. THE ISSUE WAS NOT DIAGNOSED UNTIL AFTER THEY CAME OFF BYPASS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLOW PROBE WAS ATTACHED DUE TO THE ISSUE WITH THE CUSTOM TUBING PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379947 CUSTOM TUBING PACK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF MEDTRONIC MEXICO S. DE R.L. DE CV BB1A19R53 230675447 00763000371456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown