BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY NT BALANCE

    MDR report key: 21281219 · Received January 31, 2025

    Report

    Report Number
    2184009-2025-00080
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    May 3, 2024
    Report Date
    February 18, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K191444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS THE QB-INLET PORT IS BROKEN OFF AND EVIDENCE OF CRACKS IN THE HEAT EXCHANGER HOUSING. PERFORMANCE TESTING CAN NOT BE PERFORMED WITH THE AMOUNT OF DAMAGE INCURRED. REASON FOR RETURN WAS UNDETERMINED. 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 INFO D4 (C): UPDATED THE EXPIRATION DATE ADDITIONAL INFO H4: UPDATED THE MANUFACTURE DATE 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 DURING USE OF AN AFFINITY NT OXYGENATOR, IT WAS REPORTED THAT AN ADULT CIRCULATION EXTRA-CORPORELLE (CEC) CIRCUIT WAS ASSEMBLED WITH A MEDTRONIC NT OXYGENATOR. THE CIRCUIT WAS ASSEMBLED IN THE USUAL MANNER FOR THE PATIENT. IT WAS FILLED WITH LACTATE RINGER, MANNITOL AND 50MG OF HEPARIN. WHEN THE CEC CIRCUIT WAS STARTED, THE PERFUSIONIST REALIZED THAT THE BLOOD THAT SHOULD BE ARTERIALIZED, WAS VERY DARK. A BLOOD GAS TEST WAS COLLECTED WHICH RESULTED IN A PARTIAL PRESSURE OF OXYGEN (PO2) OF ONLY 40MMHG. THE PERFUSIONIST INCREASED BLANDER SATURATION BY 100% AND THE BLOOD GAS SATURATION REMAINED LOW AT 60 MMHG. IT WAS INITIALLY VERIFIED BY THE PERFUSIONISTS IF THERE WAS ANY ERROR IN THE ASSEMBLY AND THERE WAS NOTHING OBSERVED. THE PERFUSIONISTS DECIDED TO CHECK THE COMPRESSED AIR AND OXYGEN CONNECTIONS OF THE TOWER AND NOTHING ABNORMAL WAS FOUND. THE PERFUSIONISTS DECIDED TO CHANGE THE GAS MIXER, HOWEVER, THERE WAS NO RESPONSE. THE PATIENT'S ARTERIAL BLOOD REMAINED SCRUTINOUS WITHOUT ENOUGH OXYGENATION. ALL POSSIBILITIES OF THE PERMANENT MATERIAL PART WERE RULED OUT BY MEMBRANE EXCHANGE. THE PERFUSIONISTS ADVISED THE SURGEON THAT THE ONLY SOLUTION WAS TO EXCHANGE THE OXYGENATOR BECAUSE IT COULD BE DEFECTIVE. THE CEC CIRCUIT WAS DISCONTINUED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. AFTER COLLECTION OF A BLOOD GAS SAMPLE, IT WAS VERIFIED THAT THE ISSUE OF OXYGENATION HAD BEEN RESOLVED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO CRACKS NOTED IN THE OXYGENATOR. THE CUSTOMER STATED THAT THE DOSAGE OF HEPARIN WAS MONITORED THROUGH TCA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE SHOWED EVIDENCE OF CRACKS IN THE HEAT EXCHANGER HOUSING, NOTICED WHEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441469 AFFINITY NT BALANCE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 511B 227533000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown