BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 7009347 · Received November 8, 2017

    Report

    Report Number
    9681834-2017-00231
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 8, 2017
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350769572
    PMA / PMN Number
    K040210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION FOUND THE FINDING: THE OXYGENATOR MODULE HAD COME OFF THE RESERVOIR AND THE RESERVOIR HAD BEEN DEFORMED ON THE PART TO BE FITTED TO THE OXYGENATOR MODULE. NO OTHER ANOMALIES WERE VISIBLE WITH THE NAKED EYE. COLORED SALINE SOLUTION WAS CIRCULATED IN THE BLOOD PATHWAY OF THE OXYGENATOR MODULE. IT LEAKED OUT OF BOTH LATERAL SIDES (THE GAS-IN AND GAS-OUT SIDES). WHILE THE COLORED SALINE SOLUTION WAS BEING CIRCULATED IN THE OXYGENATOR MODULE, THE FIBER WINDING WAS OBSERVED UNDER MAGNIFICATION FOR THE LOCATION OF THE LEAK. IT WAS REVEALED A LEAK WAS OCCURRING IN THE INSIDE OF THE FIBER LOCATED ON THE MOST PERIMETER OF THE FIBER WINDING. X-RAY CT EVALUATION OF THE LEAKING SEGMENT REVEALED THE URETHANE FILLING HAD BEEN CRACKED AND THE FIBER EMBEDDED THERE ALSO HAD BEEN CRACKED. A MOVIE SHOWING THE INVOLVED CUSTOMER'S COMPLAINT WAS ALSO PROVIDED FOR REVIEW. THE MOVIE CONFIRMED THE CUSTOMER'S COMPLAINT, AIR BUBBLES WERE SEEN ON THE GAS-OUT SIDE OF THE DEVICE. SIMULATION TESTING WAS CONDUCTED BASED ON THE STATE OF THE DAMAGE OBSERVED ON THE ACTUAL DEVICE, A HYPOTHESIS THAT THE ACTUAL DEVICE MAY HAVE BEEN EXPOSED TO SHOCK FORCE DURING TRANSPORTATION OR STORAGE WAS ESTABLISHED. THE REPRODUCTIVE TESTS WERE CONDUCTED AS FOLLOWS. A FACTORY RETAINED PRODUCT SAMPLE OF THE INVOLVED PRODUCT CODE WAS DROPPED FROM FIVE (5) METERS HIGH AND SUBSEQUENTLY WAS SUBJECTED TO A LEAK TEST BY CIRCULATING COLORED SALINE SOLUTION IN IT. NO LEAK OCCURRED. THE LOT NUMBER OF THE ACTUAL DEVICE INDICATES THE ACTUAL DEVICE EXPERIENCED A WINTER. A FACTORY RETAINED PRODUCT SAMPLE OF THE INVOLVED PRODUCT CODE WAS COOLED DOWN BEFOREHAND. THE SAMPLE WAS THEN DROPPED FROM FIVE (5) METERS HIGH AND SUBSEQUENTLY WAS SUBJECTED TO A LEAK TEST BY CIRCULATING COLORED SALINE SOLUTION IN IT. IT LEAKED. THE STATE OF LEAK SIMILAR TO THE ACTUAL DEVICE WAS DUPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO PREVIOUS REPORT OF THIS NATURE WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. THERE IS NO EVIDENCE THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THE ACTUAL DEVICE WAS COOLED DOWN DURING TRANSPORTATION OR STORAGE IN WINTER. IN THIS STATE, IT WAS EXPOSED TO SOME SHOCK FORCE, RESULTING IN A BREAK ON THE RESERVOIR AND THE GENERATION OF A CRACK ON THE URETHANE FILLING. SUBSEQUENTLY, WHEN THE INVOLVED CUSTOMER USED THE BROKEN UNIT, IT LEAKED. AS A CAUSE OF THE GENERATION OF THE AIR BUBBLES THE CUSTOMER OBSERVED DURING PRIMING, IT IS LIKELY WHEN GAS WAS SENT TO THE ACTUAL DEVICE THE LEAKED PRIMING SOLUTION TURNED INTO FOAM AND CAME OUT OF THE GAS-OUT SIDE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: DO NOT USE IF PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX RX25 OXYGENATOR AND RESERVOIR. 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 A DETACHED RESERVOIR IN THE CAPIOX DEVICE PRIOR TO A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: UPON OPENING THE OXYGENATOR BOX THE PERFUSIONIST FOUND THE OXYGENATOR DETACHED FROM THE RESERVOIR; THE PERFUSIONIST ATTACHED THE RESERVOIR BACK THE OXYGENATOR TO DO PRIMING; AFTER ONE HOUR OF PRIMING PRIOR TO THE CASE, THE PERFUSIONIST FOUND THE OXYGENATOR FORMING BUBBLES; AND THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. TO CORRECT THE VERIBAGE. IT WAS STATED IN THE SIMULATION TESTING IN THE INITIAL REPORT IN THE SECTION THAT: SIMULATION TESTING WAS CONDUCTED BASED ON THE STATE OF THE DAMAGE OBSERVED ON THE ACTUAL DEVICE, A HYPOTHESIS THAT THE ACTUAL DEVICE MAY HAVE BEEN EXPOSED TO SHOCK FORCE DURING TRANSPORTATION OR STORAGE WAS ESTABLISHED. THE REPRODUCTIVE TESTS WERE CONDUCTED AS FOLLOWS. A FACTORY RETAINED PRODUCT SAMPLE OF THE INVOLVED PRODUCT CODE WAS DROPPED FROM FIVE (5) METERS HIGH AND SUBSEQUENTLY WAS SUBJECTED TO A LEAK TEST BY CIRCULATING COLORED SALINE SOLUTION IN IT. NO LEAK OCCURRED. THE LOT NUMBER OF THE ACTUAL DEVICE INDICATES THE ACTUAL DEVICE EXPERIENCED A WINTER. A FACTORY RETAINED PRODUCT SAMPLE OF THE INVOLVED PRODUCT CODE WAS COOLED DOWN BEFOREHAND. THE SAMPLE WAS THEN DROPPED FROM FIVE (5) METERS HIGH AND SUBSEQUENTLY WAS SUBJECTED TO A LEAK TEST BY CIRCULATING COLORED SALINE SOLUTION IN IT. IT LEAKED. THE STATE OF LEAK SIMILAR TO THE ACTUAL DEVICE WAS DUPLICATED. IT SHOULD HAVE STATED: SIMULATION TESTING WAS CONDUCTED BASED ON THE STATE OF THE DAMAGE OBSERVED ON THE ACTUAL DEVICE, A HYPOTHESIS THAT THE ACTUAL DEVICE MAY HAVE BEEN EXPOSED TO SHOCK FORCE DURING TRANSPORTATION OR STORAGE WAS ESTABLISHED. THE REPRODUCTIVE TESTS WERE CONDUCTED AS FOLLOWS. A FACTORY RETAINED PRODUCT SAMPLE OF THE INVOLVED PRODUCT CODE WAS DROPPED FROM 1.5 METERS HIGH AND SUBSEQUENTLY WAS SUBJECTED TO A LEAK TEST BY CIRCULATING COLORED SALINE SOLUTION IN IT. NO LEAK OCCURRED. THE LOT NUMBER OF THE ACTUAL DEVICE INDICATES THE ACTUAL DEVICE EXPERIENCED A WINTER. A FACTORY RETAINED PRODUCT SAMPLE OF THE INVOLVED PRODUCT CODE WAS COOLED DOWN BEFOREHAND. THE SAMPLE WAS THEN DROPPED FROM 1.5 METERS HIGH AND SUBSEQUENTLY WAS SUBJECTED TO A LEAK TEST BY CIRCULATING COLORED SALINE SOLUTION IN IT. IT LEAKED. THE STATE OF LEAK SIMILAR TO THE ACTUAL DEVICE WAS DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787859 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 150223 04987350769572

    Patients

    Seq Age Sex Outcome Treatment
    1