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

Catalog Number CX-XRY03551

Device Problem Filtration Problem (2941)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

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.Visual inspection revealed no defects.The actual sample was fixed with glutaraldehyde solution and subjected to visual inspection.Red thrombus was found to have formed inside.The housing and filter was removed.Visual inspection of the outer and inner surfaces of the filter found the formation of red thrombus.After the above no.3, the oxygenator module was subjected to visual inspection.There was no anomaly noted in the state of fiber winding.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.The formation of red thrombus was noted.After the outer cylinder was removed from the heat exchanger module, the inside of the heat exchanger module was subjected to visual and magnifying inspections.Red thrombus was found to have formed at the bottom area.Magnifying inspection of the outer and inner surfaces of the filter found the formation of red thrombus on both surfaces.The state of the meshes, including the diameter, was confirmed to be normal.The fiber layers collected during the above inspection was inspected under magnification.The formation of red and white thrombi was found on each layer.Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion of erythrocyte components, including red blood cells, deformed red blood cells (echinocytes) and white blood cells, and the formation of fibrin net on them.Electron microscopic inspection of the fiber on each layer on the front side of the fiber winding collected revealed the adhesion of erythrocyte components, including red blood cells, deformed red blood cells (echinocytes) and white blood cells, and the formation of fibrin net on it.The involved pump record was reviewed as follows.The blood flow rate is noted to have stayed at around 4 l/min.The pressure drop (pressure at the oxygenator-in minus (-) pressure at the oxygenator-out) is noted to be kept around 100 mmhg.There is no remarkable change which could have been a cause of the thrombus formation, including an increase in the pressure drop.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 that this event was related to a device defect or malfunction.While the investigation confirmed the formation of red thrombus on the filter and on the fiber 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: "adequate heparinization of the blood is required to prevent it from clotting.Do not reduce heparin during circulation.Otherwise, blood clotting might occur." (b)(4).

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: no issue was noted during the operation.After the weaning, when collecting the blood remaining in the actual sample, the presence of thrombus was noted inside the actual sample.The procedure outcome is unknown.There was no harm to the patient.

• 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: 7029867
• MDR Text Key: 92800837
• Report Number: 9681834-2017-00238
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: CX-XRY03551
• Device Lot Number: 170609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 61