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

Catalog Number CX-FX25REV

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510k: 510(k): k130520.The actual device was received for evaluation.Visual inspection revealed that there was no anomaly such as a break in its appearance.Physiological saline solution was let to flow into the blood channel.Visual inspection of the oxygenation module found blood clots had been formed in it, however, it was not clarified when the blood clots were formed (e.G., on- or off-circulation, or during transportation back to (b)(4)).The actual sample before being rinsed was built into a circuit with tubes.Physiological saline solution was circulated in the blood channel, while the pressure drop was determined at each flow rate.The obtained values were confirmed to be higher than those obtained from a current product sample.The actual sample after rinsed and dried was built into a circuit with tubes.Bovine blood (hb12 g/dl and temp.37 deg.C) was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturing specifications.Visual inspection of the reservoir found blood clots had been formed in a part of the housing.There was no break or no deformation in the appearance.The cardiotomy filter was disassembled from the reservoir and submerged in physiological saline solution.Visual inspection of the cardiotomy filter and the defoamer inside the cardiotomy filter found that blood clots had been formed in them.The venous filter was taken out of the reservoir and submerged in physiological saline solution.Visual inspection of the venous filter and the defoamer inside the venous filter found no formation of blood clots in them.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.If circulation is to be resumed, recirculation at a low flow rate is recommended.During recirculation, check blood gas pressure.An excessive gas flow may cause low paco2, alkalosis, or blood damage.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 sample was of the normal product.It is likely that the coagulation factors were activated due to suction of blood or administration of drag, which caused the blood clot to be formed inside the oxygenator while circulation was off.Subsequently, when the circulation was re-started, the pressure drop increased.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 device was used during the procedure.When circulation was re-started, pressure increased (430mmhg, before the oxygenator).The oxygenator was exchanged with another from the same lot.Patient was not injured or harmed.The operation was finished successfully.Act=440sec.

• 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; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9309290
• MDR Text Key: 165961530
• Report Number: 9681834-2019-00194
• 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: 11/12/2019

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: 05/31/2022
• Device Catalogue Number: CX-FX25REV
• Device Lot Number: 190614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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
• Patient Outcome(s): Other