BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALFLOW SET

    MDR report key: 21737346 · Received April 1, 2025

    Report

    Report Number
    9617601-2025-00313
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 14, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJZ
    PMA / PMN Number
    K240880
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL INSPECTION SHOWED EVIDENCE OF A CLOT/FIBRIN AROUND THE UPPER PIVOT. ADDITIONAL VISUAL INSPECTION SHOWED EVIDENCE OF DAMAGE/MELTING AROUND THE UPPER PIVOT. THE DEVICE WAS PRIMED AND RUN FROM 0-3000 RPMS ON A BIO -CONSOLE WITH A FLOW OF 8 L/MIN OBSERVED. REASON FOR RETURN WAS CONFIRMED FOR CLOT/FIBRIN. 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 THE USE OF A VITALFLOW TUBE SET PUMP ON AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PATIENT, THE PUMP STOPPED, NECESSITATING A SWITCH TO AN EMERGENCY HAND CRANK. PRIOR TO THE STOPPAGE, A LOUD GRINDING NOISE WAS HEARD FROM THE PUMP. BLOOD CLOTS WERE OBSERVED AROUND THE CERAMIC BEARING OF THE PUMP. THE PATIENT WAS ADMINISTERED 2 UNITS OF CELLS AND HAD THEIR ANTI-COAGULATION INCREASED. THE VITALFLOW CONSOLE AND DISPOSABLE WERE SWITCHED TO A BACKUP SYSTEM. THE PATIENT REMAINED ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT HAD BEEN ON ECMO SINCE APPROXIMATELY (B)(6) 2025 AND THEY WERE ORIGINALLY PLACED ON A NOVALUNG DEVICE. THAT DEVICE COULD NOT FLOW AT THE LITERS REQUIRED SO THE CUSTOMER SWITCHED THE PATIENT TO A VITALFLOW AND STATED THAT THEY WERE GETTING THE FLOWS NEEDED. THE CUSTOMER WAS ABLE OBTAIN FLOW WITH THE HANDCRANK. THERE WAS NO AIR VISIBLE IN THE SYSTEM. THE AP40 WAS IN THE VERTICAL ORIENTATION AS INDICATED BY THE IFU. THE CUSTOMER STATED THAT THE SYSTEM IS ALWAYS PRIMED AND NEVER DRY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION REGARDING A BRIEF HISTORY OF THE PATIENT'S ECMO RUN PER CO-ORDINATOR: (B)(6) 2025 CANNULATED AND PLACED ON NOVALUNG, VENO-VENOUS (VV) FEMORO-FEMORAL CANNULATION 23FR & 19FR. (B)(6) 2025 PATIENT WAS REQUIRING HIGHER FLOWS, CHANGED THE CIRCUIT TO VITALFLOW, OVERTIME THERE WERE INCREASED FLOWS ON VITALFLOW. (B)(6) 2025 WENT OVER 4L OF FLOW. (B)(6) 2025 15:36- SWITCHED PATIENT CANNULA CONFIGURATION TO RIGHT INTERNAL JUGULAR VEIN (RIJ) DUAL LUMEN CANNULAS IN THE PULMONARY ARTERY (PA), (VP ECMO) 27FRSPECTRUM CANNULA. FLOWS DROP FROM AROUND 3.7 TO 2.5 L. PATIENT DID NOT TOLERATE WELL. RUNNING HIGH PRESSURES 300/290S. (B)(6) 2025, 1345, VENO-ARTERIOVENOUS (VAV) CONVERSION, ADDED FEMORAL ARTERIAL CANNULA 15FR- RPM 3200, PRESSURES DROPPED 257/230S. THE PATIENT HAS BEEN ON BIVAL FOR ANTICOAGULATION. APTT 53.7 AT TIME OF PUMP FAILURE. THERE WERE NO LEAKS, AIR OR PUMP DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527402 VITALFLOW SET EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATOR QJZ MEDTRONIC MEXICO S. DE R.L. DE CV 58112 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1