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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX25RE
Device Problem Device Operational Issue (2914)
Patient Problem No Patient Involvement (2645)
Event Date 05/12/2018
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device was returned for evaluation. Visual inspection upon receipt revealed no defects. Saline solution was filled in the blood phase. With the blood outlet port side clamped, air pressure was applied to the blood phase from the blood inlet port side, while the actual sample being observed for any leak. No leak was confirmed. The actual sample was built into a circuit with tubes. The procedures instructed in the ifu being followed, the actual sample was primed with colored saline solution. No air remained inside the oxygenator. After above test, the saline solution was circulated at the flow rate of 0. 5l/min, where an air was applied into the gas phase at 0. 5l/min - 20l/min. There was no air bubble going into the blood phase. Subsequently, the pressure inside the gas phase was increased by applying a large volume of air exceeding 20l/min into the gas phase. Air bubbles were found to be going into the blood phase. The investigation result verified that the actual sample was the normal product with no anomaly related to air entrainment. There is no evidence that this event was related to a device defect or malfunction. As a cause of this complaint, it is likely that the pressure inside the blood phase became lower than that inside the gas phase, due to which air was pulled into the blood phase through the fibers. However, the exact cause of the reported event cannot be definitively determined based on the available information. A review of the manufacturing record and the product release decision control sheet of the involved product/lot# combination was conducted with no findings. The ifu states: "do not supply gas during priming. 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". (b)(4).
 
Event Description
The user facility reported air bubbling on the involved capiox device. There are no anomalies reported to be seen on the oxygenator when user opened the box. The user started priming (no patient was involved) as usual around 9am. By 9. 30am, it was noticed that bubbles began to appear in the arterial filter which suddenly lead to the whole circuit including oxygenator and began to fill up with bubbles. It was reported that they do connect the gas supply when they prime. It was reported that according to them, it may help to clear the micro debris. It was reported that they did not use a hemoconcentrator for this case. The case was successful by using the new oxygenator and patient was reported to be safe and was not harmed.
 
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Brand NameCAPIOX RX OXYGENATOR
Type of DeviceOXYGENATOR, 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 Key7595530
MDR Text Key111166609
Report Number9681834-2018-00099
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K040210
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 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue NumberCX*RX25RE
Device Lot Number150910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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