BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX CUSTOM PACK

    MDR report key: 16128951 · Received January 10, 2023

    Report

    Report Number
    9681834-2022-00269
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 10, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: NO PATIENT INVOLVEMENT. AGE & DATE OF BIRTH: NO PATIENT INVOLVEMENT. PATIENT SEX: NO PATIENT INVOLVEMENT. WEIGHT: NO PATIENT INVOLVEMENT. ETHNICITY: NO PATIENT INVOLVEMENT. RACE: NO PATIENT INVOLVEMENT. UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: NO PATIENT INVOLVEMENT. EXPLANTED DATE: NO PATIENT INVOLVEMENT. OCCUPATION - CLINICAL ENGINEER. PMA/510(K): K071494, K130520. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REVIEW OF THE MANUFACTURING RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT NUMBER COMBINATION CONFIRMED THERE WERE NO ANOMALIES IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT OBTAINED THE FOLLOWING RESULTS. THE RESERVOIR WAS FILLED WITH PHYSIOLOGICAL SALINE SOLUTION. FORMATION OF BLOOD CLOTS WAS OBSERVED IN THE VENOUS FILTER (NEAR THE OUTLET PORT OF THE RESERVOIR). NO BREAKAGE WAS OBSERVED IN THE APPEARANCE. THE ACTUAL SAMPLE WAS DISASSEMBLED. VISUAL INSPECTION OF THE VENOUS FILTER AND THE VENOUS FILTER DEFOAMER OBTAINED THE FOLLOWING RESULTS. FORMATION OF BLOOD CLOTS WAS OBSERVED ON THE INNER SURFACE OF THE VENOUS FILTER. THERE WAS NO BLOOD CLOT ON THE DEFOAMER. VISUAL INSPECTION OF THE CR FILTER AND THE CR FILTER DEFOAMER OBTAINED THE FOLLOWING RESULTS. THERE WAS NO BLOOD CLOT ON THE CR FILTER. FORMATION OF BLOOD CLOTS WAS OBSERVED ON THE INNER SURFACE OF THE DEFOAMER. AFTER THE BLOOD CLOTS WERE COLLECTED, THE VENOUS FILER AND THE CR FILTER DEFOAMER WERE FIXED WITH GLUTARALDEHYDE AND SUBJECTED TO ELECTRON MICROSCOPIC INSPECTION. RED BLOOD CELLS DEFORMED RED BLOOD CELLS (ECHINOCYTE), AND FORMATION OF FIBRIN NET WERE OBSERVED. AFTER, THE VENOUS FILTER WAS SUBJECTED TO MAGNIFYING INSPECTION. NO ANOMALY WAS OBSERVED ON ITS INNER AND OUTER SURFACES. THE INVESTIGATION RESULTS SHOWED FORMATION OF BLOOD CLOTS IN THE VENOUS FILTER AND THE CR FILTER DEFOAMER OF THE ACTUAL SAMPLE. AS A CAUSE OF OCCURRENCE, IT WAS THOUGHT THAT THE COAGULATION FACTORS CONTAINED IN THE MAP USED FOR PRIMING WAS ACTIVATED FOR SOME REASONS, WHICH RESULTED IN THE FORMATION OF BLOOD CLOTS. FROM THE INVESTIGATION RESULT OF THE ACTUAL SAMPLE, THE CAUSE OF THE FORMATION OF BLOOD CLOTS COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: DO NOT SUPPLY GAS DURING PRIMING.(B.PRIMING PROCEDURE CAUTION).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING BLOOD PRIMING, BLOOD CLOT-LIKE SUBSTANCE WAS OBSERVED ON THE VENOUS FILTER (ADJACENT TO THE OUTLET PORT) OF THE RESERVOIR WITH THE INVOLVED CAPIOX CUSTOM PACK DEVICE. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188885 CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 220613

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown