BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 8435518 · Received March 20, 2019

    Report

    Report Number
    9681834-2019-00026
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    February 20, 2019
    Report Date
    March 20, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED E1: ESTABLISHMENT NAME: (B)(6) HOSPITAL G5: 510(K) K130280 THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UPON RECEIPT FOUND A SUBSTANCE WHITE IN COLOR ADHERING TO THE INSIDE WALL ON THE GRADUATION SIDE. THERE WAS NOT ANY OBVIOUS ANOMALY, SUCH AS A BREAK, IN THE APPEARANCE. THE ACTUAL DEVICE WAS DISASSEMBLED AND THE FOREIGN SUBSTANCE WHITE IN COLOR WAS COLLECTED. SEM-EDX (SCANNING ELECTRON MICROSCOPE - ENERGY DISPERSIVE X-RAY SPECTROMETRY) ELEMENTARY ANALYSIS OF THE FOREIGN SUBSTANCE DETECTED SOME ELEMENTS CONSTITUTING ORGANIC SUBSTANCES, INCLUDING NITROGEN AND SULFUR. FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) QUALITATIVE ANALYSIS OF THE FOREIGN SUBSTANCE OBTAINED THE SPECTRUM OF PROTEIN. THE CARDIOTOMY FILTER AND THE DEFOAMER TAKEN OUT OF THE CARDIOTOMY FILTER, AFTER HAVING BEEN RINSED IN PHYSIOLOGICAL SALINE SOLUTION, WERE SUBJECTED TO VISUAL INSPECTION. THE PRESENCE OF CLOTS WAS NOTED ON THE DEFOAMER. BASED ON THE INVESTIGATION, THE FOREIGN SUBSTANCE WHITE IN COLOR ADHERING TO THE INSIDE WALL OF THE ACTUAL SAMPLE WAS FOUND TO BE PROTEIN DERIVED FROM A LIVING BODY. SOME CLOTS WERE FOUND TO HAVE FORMED ON THE DEFOAMER OF THE CARDIOTOMY FILTER. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY WHEN BLOOD IN WHICH COAGULATION FACTORS HAS BEEN ACTIVATED FLOWS INTO THE RESERVOIR AND STAYED ON THE SOLUTION LEVEL, CLOTS MAY START TO FORM THERE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING THE CIRCULATION, THE CUSTOMER FOUND A FOREIGN SUBSTANCE WHITE IN COLOR, WHICH HE THOUGHT WAS A WHITE THROMBUS, ADHERING TO THE INSIDE WALL OF THE RESERVOIR ON THE AREA AROUND THE GRADUATION OF 600ML. THE CUSTOMER COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT CHANGING OUT THE ACTUAL SAMPLE AND THERE WAS NO BLOOD LOSS OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229957 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 181023

    Patients

    Seq Age Sex Outcome Treatment
    1