MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX15RE30

Device Problem Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required.The actual device was returned to the manufacturing facility for evaluation.Photos that show the state of the actual sample during the time of use were also returned and reviewed.The presence of red thrombus was confirmed on the actual device.Visual inspection of the actual device found red thrombus adhering to the surface of the fiber inside the oxygenator.There was no obvious anomalies.The actual device was rinsed with saline solution and subjected to another visual inspection.The adhesion of red thrombus was found on the upper, front and back sides of the oxygenator.The actual device was fixed with glutaraldehyde solution.The housing was removed and the gas exchange module was directly inspected.The adhesion of red thrombus was noted.The filter was removed.No anomalies were revealed in the state of the fiber winding.The fiber layer was removed from the winding in increments of 4 mm and each layer was subjected to visual inspection.The adhesion of red thrombus was found mainly on the back side.The filter removed from the oxygenator was inspected under magnification.The adhesion of red thrombus was found on the outside surface.The fiber layers removed were inspected under magnification.Moore red thrombus was found on the outer circumferential side than on the inner side (heat exchanger side).The heat exchanger module was subjected to visual inspection once all the fiber and the outer cylinder was removed.A light amount of red thrombus was found to be adhering to the upper part.A review of the device history record from the reported product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lo number combination.There is no evidence that this event was related to a device defect or malfunction.During inspection, the thrombus formation was found in the gas transfer module.The circulation conditions, including the blood flow rate and the back pressure, and /or the state of the patient's blood such as act may have affected the thrombus formation.The exact cause of the reported event cannot be definitively determined based on the available information.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 reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported clotting in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: 100% of autologous blood was used in this procedure; after the pump was off, adhesion of clots in streaked and patched appearance was found inside the oxygenator module; the patient's blood was sampled one month prior to the date of the procedure and the patient continued using cpda-1 (citrate phosphate dextrose adenine) solution; at 12:12 blood sampling = act441; 12:13 administration of the autologous blood 300 ml (containing citric acid); 12:24 heparin 3 ml; 12:25 administration of the autologous blood 300 ml; and 12:42 completion of the extracorporeal circulation, when the customer noticed the adhesion of clots.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6832901
• MDR Text Key: 84366208
• Report Number: 9681834-2017-00179
• 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
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: CX-FX15RE30
• Device Lot Number: 170426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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