MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF

Model Number N/A

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although this patient was reported to be unaffected, the event description indicates that the oxygenator was changed out during use.Therefore, some blood loss was associated with this event.The actual device has returned to the manufacturer for evaluation.Visual inspection of the reservoir did not find any visible break on it.Red thrombus was found to have formed in the lower part of the cr filter, the upper and lower parts in the venous filter.The reservoir was disassembled for further inspection.Visual inspection of the cr filter and the de-bubbling material set inside the cr filter found the adhesion of red thrombus on their insides and outsides.The cr filter and the de-bubbling material were rinsed and inspected under electron microscope, no anomalies were noted.The reservoir was disassembled for further inspection.Visual inspection of the venous filter and the de-bubbling material set inside the venous filter found the adhesion of red thrombus on their insides and outsides.The venous filter and the de-bubbling material were rinsed and inspected under electron microscope, no anomalies were noted.Visual inspection of the oxygenator module found no visible anomalies.The blood pathway was rinsed with saline solution and visual-inspected.Red thrombus was found to have been formed in its inside.The oxygenator module was fixed with glutaraldehyde solution.The housing component and filter were removed.The filter was subjected to unaided and magnifying inspections.On both the outer and inner surfaces, the formation of white and red thrombi was found.Subsequently, the fiber winding was subjected to visual inspection.There was no anomaly in the state of the fiber winding.The fiber layer was removed from the winding in increments of 4mm and each layer was subjected to visual inspection.Red thrombus was found to have formed all over the fiber winding.After all the fiber layers were removed, the outer cylinder of the heat exchanger module was visually inspected.Red thrombus was found to have formed between the outer cylinder and the heat exchanger module.After the outer cylinder was removed, the heat exchanger module was visually inspected.Red thrombus was found to have formed on it.The fiber was rinsed, dried and inspected under electron microscope.The diameter of the mesh was confirmed to be in the normal state.Electron microscopic inspection of the fiber on each layer on the front aspect of the fiber winding revealed the formation of fibrin net and the adhesion of echinocyte and erythrocyte components consisting of red and white blood cells and blood platelets on the layer after 12mm was removed.A review of the dhr of the involved product/lot# combination confirmed there were not any indications of production-related problems.A search of the complaint file found no previous report of this nature with the involved product /lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information, it is likely that thrombus formed inside the reservoir flowed into the oxygenator module and obstructed the blood flow inside the oxygenator module.Due to some factor(s) red blood cells were changed into echinocyte and obstructed the blood flow inside the oxygenator module.As a cause of the formation of thrombus inside the reservoir, it is likely that blood in which a coagulation factor had been activated by the sucker flowed into the reservoir and stagnated there.The device labeling does address the potential for such an event in the instruction for use (ifu) with statements such as the following: (1) adequate heparinization of the blood is required to prevent it from clotting in the system; and (2) do not reduce heparin during circulation.Otherwise, blood clotting might occur.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

Event Description

The user facility reported thrombus formed during the priming of the capiox fx25 device.Follow up communication with the user facility reported the following information: (1) an operation for cabg 3 branches + avr was being conducted; (2) thrombus formed during the priming stage; (3) after the oxygenator setting, heparin injection and cannulation were conducted; (4) blood was being suctioned with a sucker only in the bleeding area; (5) during the stand-by with the arterial line clamped, waiting for pump-on with no gas flow, blood was being circulated not in the recirculation line but in the purge line; (6) as the patient's blood pressure decreased to 70mmhg level, the arterial line was de-clamped with the pump speed @ 1500rpm, blood flow rate @100ml/min.; (7) the pressure before the oxygenator: 243mmhg, after the oxygenator @ 70mmhg.The back flow alarm went off; (8) during this period, a hemoconcentrator was used to concentrate blood, the waste liquid was 1,000ml; (9) as blood clotting was observed in the reservoir, the involved devices as well as the oxygenator were replaced with new ones except for the venous and arterial lines; (10) the blood left in the oxygenator in question and connected devices was about 1,000ml, it was not confirmed how much of the blood was used for the new oxygenator; (11) the operation was completed successfully; and (12) there was no harm to the patient.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: kathleen little ; reg. no. 2243441; 2101 cottontail ln.; summerset, NJ 08873 ; 8002837866
• MDR Report Key: 5010017
• MDR Text Key: 23247817
• Report Number: 9681834-2015-00176
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/22/2015,08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX39501
• Device Lot Number: 150422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/22/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other