BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 11892383 · Received May 27, 2021

    Report

    Report Number
    9681834-2021-00093
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 27, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. AN IMAGE WAS PROVIDED BY THE USER; THE MOVIE PROVIDED BY THE USER SHOWED THAT A 3/16 ADAPTER WAS CONNECTED TO THE BLOOD OUTLET PORT AND LEAK WAS OBSERVED FROM THE CONNECTION AREA. VISUAL INSPECTION OF THE SAMPLE REVEALED A DEFORMITY OF THE BLOOD OUTLET PORT TO WHICH THE 3/16 ADAPTER WAS ATTACHED. NO BREAKAGE OR OTHER VISIBLE ANOMALY WAS NOTED IN OTHER PARTS. THE ACTUAL SAMPLE WAS BUILT INTO CIRCUIT WITH TUBE, AND COLORED NORMAL SALINE WAS CIRCULATED. AS A RESULT, LEAK FROM THE CONNECTION BETWEEN THE BLOOD OUTLET PORT AND THE 3/16 ADAPTER WAS CONFIRMED. THE 3/16 ADAPTER WAS REMOVED FROM THE ACTUAL SAMPLE. MAGNIFYING INSPECTION OF THE BLOOD OUTLET PORT FOUND NO CRACK OR OTHER ANOMALY THAT COULD LEAD TO LEAK. MAGNIFYING INSPECTION OF THE 3/16 ADAPTER FOUND NO DEFORMATION OR BREAKAGE OF SCREW THREAD. SIMULATION TEST: FROM THE DEFORMATION OF THE BLOOD OUTLET PORT OF THE ACTUAL SAMPLE, IT WAS ASSUMED THAT THE BLOOD OUTLET PORT HAD BEEN SUBJECTED TO SOME LOAD AT SOME POINT AFTER THE ADAPTER WAS ATTACHED TO IT, LEADING TO THE LEAK. BASED ON THIS ASSUMPTION, AN ADAPTER WAS ATTACHED TO A FACTORY-RETAINED SAMPLE AND THEN A LATERAL TENSILE LOAD WAS APPLIED TO THE TUBE. AS A RESULT, THE BLOOD OUTLET PORT WAS SLIGHTLY DEFORMED, RESULTING IN A LEAK. IFU STATES: ENSURE THAT ALL CONNECTED PARTS INCLUDING THE LUER CAPS, THE LOCK ADAPTERS AND THE PORT CAPS ARE SECURELY AFFIXED. LOOSE CONNECTIONS MAY CAUSE CONTAMINATION OR A BLOOD LEAK. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE BLOOD OUTLET PORT OF THE ACTUAL SAMPLE WAS DEFORMED, CREATING A LEAK PATH AT THE CONNECTION WITH THE 3/16 ADAPTER. SINCE THE RED CAP IS ATTACHED TO THE BLOOD OUTLET PORT DURING THE MANUFACTURING PROCESS AND THE 3/16 ADAPTER IS CONNECTED DURING USE, IT WAS THOUGHT THAT SOME KIND OF LOAD WAS APPLIED TO THE BLOOD OUTLET PORT AFTER THE 3/16 ADAPTER WAS CONNECTED TO IT. HOWEVER, IT COULD NOT BE CLARIFIED WHEN THE DEFORMATION OCCURRED FROM THE CONDITION OF THE ACTUAL SAMPLE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- KLINSCH PERFUSIONIST. PMA/510(K)- K130280. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE CAPIOX DEVICE LEAKED. THE OPERATOR FOUND LEAKAGE AT THE BLOOD OUTLET OF RESERVOIR DURING PRIMING. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794208 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200703C 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1