BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 22684505 · Received August 1, 2025

    Report

    Report Number
    9612164-2025-03762
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 15, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QHW
    UDI-DI
    00763000876876
    PMA / PMN Number
    K240534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF A CRACK IN THE CANNULA LUER PORT. EVIDENCE OF THE LEAK HAS BEEN PROVIDED. THE DEVICE WAS CONNECTED TO A WATER SUPPLY AND WITH 0.5 LPM FLOWING AND LESS THAN 1 PSI OF BACK PRESSURE THERE WAS A LEAK OBSERVED FROM THE CRACKED LUER PORT. REASON FOR THE RETURN WAS CONFIRMED. CORRECTION D3. MFR NAME & D3.6: THESE FIELDS WERE UPDATED. 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

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE CATHETER WAS PLACED AT THE POSITION OF THE FEMORAL ARTERY AND FEMORAL VEIN IN THE RIGHT LEG. THE CATHETER WAS USED FOR 3 DAYS BEFORE THE CANNULA BODY RUPTURED. CORRECTION D3 (MFR NAME) <(>&<)> D3.6 (POSTAL CODE): THESE FIELDS HAVE BEEN UPDATED. CORRECTION G4.4 (PMA / 510(K) #): THIS FIELD HAS BEEN UPDATED. CORRECTION H6 (PATIENT CODES (IME/ANNEX E)): THESE CODES HAVE BEEN UPDATED. 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 THE PATIENT SUFFERED A SUDDEN MYOCARDIAL INFARCTION AND WAS HOSPITALIZED. DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA THERE WAS BLEEDING FROM THE LOWER END OF THE VENT HOLE DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) USE. ON THE AFTERNOON OF THE THIRD DAY OF ECMO TRANSFER, A NURSE INSPECTED THE WOUND AND DISCOVERED BLEEDING FROM THE CANNULA BODY. THE CLINICIAN DECIDED TO CHANGE THE LEFT LEG AND RE-CANNULATED THE FEMORAL ARTERY. THEREFORE, THE CANNULA SITE IN THE RIGHT LEG WAS INJURED AND SUTURED. DURING THE REPLACED POSITION PROCESS, THE PATIENT LOST A TOTAL OF 500-600 ML OF BLOOD, RESULTING IN CARDIAC ISCHEMIA AND BLOOD PRESSURE DROPPED, HIGH PRESSURE WAS 70 MMHG. THIS WAS DIAGNOSED AS A MALIGNANT ARRHYTHMIA. THE DOCTOR TRANSFUSED THE PATIENT 6 UNITS OF RED BLOOD CELLS AND ADMINISTERED 11 MICROGRAMS/KG OF VASOPRESSORS. ON THE FOURTH DAY OF TRANSFER THE PATIENT'S HEALTH INDICATORS GRADUALLY RECOVER, AND HE WAS ASLEEP. THE DOCTOR WAS CLOSELY MONITORING THE PATIENT'S CONDITION. IF THE VITAL SIGNS REMAIN STABLE, THE CANNULA AND MACHINE WERE EXPECTED TO BE REMOVED IN 2-3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224210 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO S. DE R.L. DE CV LS96218-017 227145845 00763000876876

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention