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

Catalog Number CX*FX05RW

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k)- k130280. The actual device was returned for evaluation. Visual inspection upon receipt did not find any obvious anomalies. The actual sample was built into a circuit with tubes and primed with colored saline solution in accordance with the ifu for this product. There was no air remaining inside the actual sample. The blood phase was filled with saline solution. With the blood outlet port clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port. No leak was confirmed. The actual sample was then circulated with bovine blood (@37oc and hb12g/dl) at the back pressure of 200mmhg and at each blood flow rate of 0. 5l/min. , 1. 0l/min. , and 1. 5l/min. During circulation at each flow rate, an air of 10ml was sent into the circulation in 30 seconds. No air came through the filter out of the oxygenator module. A bubble trap was connected into the blood outlet port line and air was sent into the oxygenator module from the blood inlet port, while the circuit was closely observed for any presence of air going into the oxygenator module and the bubble trap. A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no findings. Ifu reference: make sure the circuit and the purge line are not clamped, then start pump at a low speed. After checking for leakage or any other problem, gradually increase flow above 0. 5 l/min, but do not exceed 1. 5 l/min. Vigorously recirculate the priming fluid through the entire circuit until all air bubbles are eliminated. After all air bubbles are eliminated, circulate at full flow for 10 min to check oxygenator and tubing for leakage or any other problem. During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force. Do not obstruct gas outlet port. Avoid build up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase. Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase. The gas flow rate should not exceed 5 l/min. Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase. To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line. The blood flow rate of the cardioplegia line should not exceed 1 l/min. The investigation verified that the returned device to be the normal product. There is no evidence that this event was related to a device defect or malfunction. It is likely that the that the pressure inside the oxygenator module became negative and due to this air was pulled inside the oxygenator module through the fibers. It is experientially known that the pressure inside the oxygenator module may become negative when the flow of the prime going into the oxygenator module has been cut off by a sudden stop of the roller pump or the application of a clamp, while the prime inside the oxygenator module is still flowing out of the oxygenator by inertial force. 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 they primed the capiox fx05 device, with crystal solution and clamped all of the tubes. The perfusionist found lots of bubbles appearing in the oxygenator chamber. He replaced the device with another fx05 device to complete the open heart surgery. The event occurred pre-treatment.

• 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; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 7628764
• MDR Text Key: 112458775
• Report Number: 9681834-2018-00109
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 180227C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial