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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRY10901
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 07/20/2018
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The 510(k): k130520. The actual device was not returned for evaluation. However, a photograph of the involved device was provided for evaluation. Therefore, the investigation was based upon evaluation of user facility information, a photograph of the involved device and a retention sample of the involved product code/lot# combination. The photograph revealed the presence of a liquid inside the actual device on the gas-out side. The retention sample from the same fiber lot# as the one used for the actual device was subjected to visual inspection and it was confirmed no anomalies, such as a break. The retention sample was circulated with bovine blood at the flow rate of 5l/min. , and at the back pressure of 500mmhg. For six hours. After this, gas was swept into the retention sample from the gas-in side. No plasma leak occurred. The ifu states: a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers. This may occur when oxygenators are used for a longer period of time. If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance. Increase gas flow rate, to 15l/min for 10 seconds. Do not repeat this flushing technique, even if oxygenator performance is not improved. A review of the device history record of the involved product code/lot number combination revealed no findings. A search of the complaint file found no previous report of this nature with the involved product /lot# combination. The investigation results verified that the retention sample from the same fiber lot number as the one used for the actual device was the normal product with no occurrence of plasma leak. As a cause of the reported plasma leak, it is likely due to a change in the blood properties due to some factor(s), a surface-active substance may be generated in blood. This may lead the balance of the surface tension between the gas and blood which is kept at the micro pores on the surface of the fibers to be upset, resulting in plasma leak. However, it is difficult to determine the definitive cause of this complaint. (b)(4).
 
Event Description
The user facility reported a plasma leak with the involved capiox fx device. A plasma leak occurred four and half hours after the initiation of the circulation. The actual sample was changed out. The amount of blood loss is unknown. The procedure outcome is unknown. The patient passed away two days after the operation. It was reported by the involved hospital that the death did not have any cause-and -effect relationship with this complaint.
 
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Brand NameCAPIOX FX 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
mark vornheder
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
8002837866
MDR Report Key7766670
MDR Text Key116526672
Report Number9681834-2018-00139
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
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 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberCX-XRY10901
Device Lot Number171116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/09/2018 Patient Sequence Number: 1
Treatment
CELL SAVER & HAS II
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