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

Catalog Number CX*RX15RW40

Device Problem Pressure Problem (3012)

Patient Problem Blood Loss (2597)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

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 review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.A search of the complaint file found no other report of this nature with the involved product code/lot# combination.(b)(4).

Event Description

The user facility reported a high pressure drop in the absence of gas exchange alteration on the involved capiox device.Entered in bypass with patient in ventricular fibrillation, heparin done during fv and it added in the prime (10.000 u/i).After 10 minutes on by pass with a flow of 4900 ml / min and act higher than 480 there was an increase of oxy inlet pressure (440 mmhg) and a normal outlet pressure (70 mmhg) without alteration of the gaseous exchanges (gas blender fio2 at 60% and 2.5 l / m of air).All the measures envisaged to decrease the pressure drop (add of albumin and sodium nitroprusside) did not have any results so it was decided to decrease the temperature and replace the oxygenator.Blood loss was reported to be 400 ml.The procedure outcome is unknown.Finla patient impact is unknown.

Manufacturer Narrative

It was initially reported that the actual device was available.It has now been reported that the actual device is no longer available.Therefore, the investigation is based on evaluation of the user facility information and a retention sample from the reported product code/lot number combination.Visual inspection revealed no anomalies, such as a break, in the appearance.The retention sample was built into a circuit.Bovine blood was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturer specifications.No obstruction inside the oxygenator module was found.After the above test, bovine blood was kept circulated for six hours.No obstruction occurred.When the circulation was ceased, the oxygenator module was flushed with saline solution.No clot was found inside the oxygenator module.The investigation result verified that the retention sample was the normal product.As a cause of this complaint, it is likely due to some factor(s), clots formed and obstructed the actual sample.With the absence of the actual sample to evaluate, the exact cause of the reported event cannot be definitively determined based on the available information.The ifu 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.".

• Brand Name: CAPIOX RX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7613665
• MDR Text Key: 111470560
• Report Number: 9681834-2018-00107
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350771094
• UDI-Public: 04987350771094
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: CX*RX15RW40
• Device Lot Number: 170822
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 67