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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.
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Manufacturer (Section D)
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
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 Key7628764
MDR Text Key112458775
Report Number9681834-2018-00109
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
Number of Events Reported1
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 Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberCX*FX05RW
Device Lot Number180227C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial