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Catalog Number CX*FX05RW
Device Problems Connection Problem (2900); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier - requested, not provided, age and date of birth - requested, not provided, sex - requested, not provided, weight - requested, not provided, ethnicity - requested, not provided, race - requested, not provided, implanted date: device was not implanted, explanted date: device was not explanted. The actual device was returned for evaluation. Visual inspection revealed no defects. The actual sample, after having been rinsed and dried, was subjected to another visual inspection. No anomaly was confirmed. Colored saline solution was circulated in the actual sample. No leak was detected at any of tube joints. After the above test, the inside of the oxygenator module was pressurized at 1000 mmhg. No leak occurred. Bovine blood was circulated in the actual sample at each blood flow rate of 0. 5 l/min. , 1. 0 l/min. And 1. 5 l/min with the back flow rate set to 200 mmhg, while an air of 10 ml was applied to the oxygenator for 30 seconds. There was no outflow of air from the oxygenator module through the filter. After the above test, the fluid level in the reservoir was decreased down to 45 ml and bovine blood was circulated in the actual sample at the flow rate of 1. 0 l/min. No entrance of air was confirmed. 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. A search of the complaint file did not find any other report with the involved product/lot combination. 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. Although the exact cause cannot be determined based on the investigation result, it is likely that the loose connection of the cannula suctioned air into the venous line and the excessive amount of air which exceeded the capacity of the filters in the reservoir and oxygenator flowed into the actual sample and observed in the upper area of the oxygenator module. The device labeling does address the potential for such an event in the instructions-for-use, which states: when capiox fx05 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir. This prevents gaseous emboli from entering the blood phase from the gas phase. Do not obstruct gas outlet port. Avoid buildup 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. 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. To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate in the cardioplegia line. The blood flow rate of the cardioplegia line should not exceed 0. 5 l/min. (b)(4).
Event Description
The user facility reported air bubbling on the capiox device. It was reported that air was sucked down the venous line due to the cannula not being attached tightly approximately 15 minutes into case. The level sensors were working and the level in the reservoir was at 45 -55 mls. The bubble detector was alarmed and air was seen in the boot pump and the top of the oxygenator. The oxygenator was clamped off and recirculated for 46 seconds until no air was seen, then clamped and the case continued. The low level alarm was set at 40 mls on the reservoir and the level at the time of incident was approximately 45 mls in reservoir (above the low level alarm sticker) flows of approximately 1 lpm and temperature 36 degrees celsius. A moderate amount of venous air came down the ¼" venous line and a few seconds later the bubble alarm was triggered stopping the pump (the low level alarm was not triggered and there was volume still in the reservoir at that point) the arterial line and venous line were clamped and proceeded to recirculate through the recruit lines/shunts and visually inspected the tubing and oxygenator. A small amount of air was seen in the pump boot that came from the bottom of the venous reservoir and a small amount of air at the top of the oxygenator and in the de-airing line from top of oxygenator to reservoir. The patient was off of bypass for approximately 46 seconds then safely went back on bypass and with no further alarms noted. Terumo ifu states a safe operating level of 15 mls and we normally run above 40 mls and closer to 50-60 mls in reservoir as our minimum - often volume is higher than that >100 mls).
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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
2101 cottontail ln.
somerset, NJ 08873
MDR Report Key7322908
MDR Text Key102123787
Report Number9681834-2018-00023
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberCX*FX05RW
Device Lot Number171031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial