MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 1ZZ*HC05SA

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.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 decision control sheet of the involved product code/lot# combination was conducted with no findings.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved capiox hemoconcentrator clotted off during cardiopulmonary bypass.There was no delay with the procedure due to the event.Surgery was completed successfully with little loss of blood (under 100cc's).Due to both hemo and oxy clotted, the patient was asked if they had any underlying issue and they said no; however, they did give donor blood.The patient was reported to be fine.They started up with the hemoconcentrator, it clogged up and was changed out before going on bypass.When they were trying to go on bypass, the oxygenator clotted off.They changed out he oxygenator and the reservoir.All throughout the case, they noticed a huge buildup of clot form in the venous sat.There was no injury to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 9681834-2020-00092.The actual haemoconcentrator and the oxygenator were received for evaluation.Inspection of the actual haemoconcentrator sample: review of the image of the actual sample as received by the us factory revealed that blood clots had been formed at both the outlet and inlet sides.About the timing of clots formed, it could not be clarified (if it was during use or the return transportation).Visual inspection of the actual sample revealed no anomaly including visible damage in the appearance.Visual inspection of the actual sample after rinsed revealed no breakage or any other anomaly that could lead to a clogging of fiber.The actual sample was built into a circuit with tubing, and then the pressure drop was determined while bovine blood (hct 25%, temp.37°c) was circulated at a flow rate of 500 ml/min and tmp of 400 mmhg.The obtained value met the manufacturer specification and no anomaly was noted.Inspection of the actual oxygenator sample: review of the image of the actual sample as received by the us factory revealed that blood clots had been formed in the blood channel.About the timing of clots formed, it could not be clarified (if it was during use or the return transportation).Visual inspection of the actual sample revealed no anomaly including visible damage in the appearance.The actual sample was rinsed, dried, built into a circuit with tubing, and then the pressure drop was determined while bovine blood (hct 35%, temp.37°c) was circulated at a flow rate of 1.5l/min.The obtained value met the manufacturer specification and no clogging was noted.Subsequently, physiological saline solution was flown into the blood channel.No formation of clot was observed.Capiox hemoconcentrator: ifu regarding formation of blood clot states: adequate heparinization of the blood is required in order to prevent it from clotting in the system.The capiox hemoconcentrator is designed to operate at flow rates within the range of 100 to 500 ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100 ml/min blood flow may cause blood coagulation in the device.Do not exceed 50% hematocrit at the blood outlet during ultrafiltration.Do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow of least 50 ml/min is recommended even if ultrafiltration is stopped by clamping the filtrate line.Bubbles in the system may cause clotting and blood damage.Capiox fx05: ifu regarding formation of blood clot states: 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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned samples were of the normal product.Based on the description of the event, "it started up with the hemoconcentrator, it clogged up and was changed out before going on bypass", the blood coagulation factor may have been activated due to some factors during circulation/ultrafiltration performed before the cpb started, which may have resulted in the formation of blood clot in the haemoconcentrator and the oxygenator.However, since the detailed description of the event was not available, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10110870
• MDR Text Key: 202393231
• Report Number: 9681834-2020-00093
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1ZZ*HC05SA
• Device Catalogue Number: ZZ*HC05SA
• Device Lot Number: 190927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1