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

Catalog Number CX-XRX30212

Device Problem Increase in Pressure (1491)

Patient Problem Blood Loss (2597)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The 510k - k130520.The actual sample was returned for evaluation.Visual inspection revealed no anomalies.The actual device was built into a circuit with tubes.Saline solution was circulated in the circuit and the pressure drop was determined at each flow rate; in this circulation test, the upper limit of the flow rate was set to 1.5l/min.Based on the involved perfusion record which indicates that the flow rate immediately before the addition of the second oxygenator to the circuit was around 1.7l/min.The pressure drop of the actual device was found to be higher than that of the current product.Unaided visual inspection revealed no visible clot formation.The actual device was fixed with glutaraldehyde solution and the housing component and filter were removed.The outer and inner surfaces of the filter were subjected to unaided visual inspection, no visible clot formation was found.The state of the fiber winding was confirmed to be normal.The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection, there was no clot formation visible with the naked eye on the fiber winding.The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.The presence of some clots was noted on the bottom area of the oxygenator.The clots were likely to be a cause of the reported increase in the pressure inside the actual device.The filter was subjected to magnifying inspection.On either of the outer or inner surfaces, no presence of clots was confirmed.There was not any anomaly in the mesh diameter of the filter.The fiber layers removed during the test were inspected under magnification, any clot formation which could have been a trigger of a pressure rise inside the actual device was not found.Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion of erythrocyte components, including white blood cells and blood platelets, on them.Any clots which could have been a trigger of the reported pressure rise in the actual device were not found on them.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding obtained revealed the adhesion of erythrocyte components, including blood platelets, and formation of fibrin net on them.Any clots which could have been a trigger of the reported pressure rise in the actual device were not found on them.Clots formed on the heat exchanger module were collected and inspected under electron microscope.The aggregation of erythrocyte components, including blood platelets, was revealed.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.The perfusion record from the involved procedure was reviewed as follows: the circulation was initiated at 10:31 with the arterial blood temperature at 34.3oc.The arterial blood was cooled down on the initiation of the circulation and at 10:52 its temperature reached 17.5 oc.Whereas, the pressure before the membrane which had been 143mmhg at the initiation of the circulation reached 395mmhg at 10:52.With an increase in the arterial blood temperature to 28.1oc at 11:01, the pressure before the membrane stayed high.At 10:35, the rpm started to be stable at 3800 rpm, whereas the blood flow rate showed a gradual decrease till 10:50.From these, it is likely that the actual device started to get obstructed during this period.There was no record of act in the involved perfusion record.Based on the information provided additionally, act at the initiation of the circulation was 140 seconds.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that pressure rise in the oxygenator module occurred during cool-down of the arterial blood shortly after the initiation of the circulation, cold agglutination may have occurred, leading to agglutination of red blood cells in the gas transfer phase.The initiation of the circulation with low act accompanied with suctioning blood caused blood and air to get mixed with each other.By this, the coagulation factors in the blood were activated and clots formed around the blood inlet section on the bottom part of the actual device and plugged the flow pass way.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox was used in an emergency a-type arterial dissection case.Due to the arterial rupture, an urgent extracorporeal circulation was required.With administration of heparin and the circulation was started immediately with act around 140.Due to massive bleeding, blood was suctioned and returned to the cardiac apex.A pressure higher than normal was noted immediately after the initiation of the circulation.Cooling was carried out immediately after the initiation of the circulation.The pressure, however, continued to increase gradually.With cold agglutination being suspected, cooling was paused.This, however, did not work and the pressure reached around 400, when another oxygenator was added to the circuit without stopping the circulation.After this, the procedure was proceeded with no further issue.The final patient impact was reported to be unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8674011
• MDR Text Key: 147162193
• Report Number: 9681834-2019-00082
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CX-XRX30212
• Device Lot Number: 190130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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
• Treatment: HEPARIN
• Patient Outcome(s): Other