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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX43502
Device Problems Coagulation in Device or Device Ingredient (1096); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation: clinical engineer. Pma/510(k)- k130520. A picture and the actual sample were provided by the user facility. The provided picture showed that the blood level in the reservoir was around 1000 ml, while the venous filter stained red by blood up to the upper part. Blood clots were observed in a part of the housing. Visual inspection of the actual sample revealed no damage or other external anomaly. Blood was found adhering to a part of the housing. The venous filter and the defoamer of the venous filter were soaked in normal saline, and then subjected to visual inspection. Blood clots had formed on the upper part of the inner surface of the venous filter and the outer surface of the defoamer. No formation of blood clots was observed in the lower part of the inside of the venous filter. The venous filter was soaked in physiological saline solution, and then subjected to visual inspection. Blood clots were found on the upper part of the inner surface. The defoamer in the venous filter was soaked in physiological saline solution, and then subjected to visual inspection. Blood clots were found on the outer surface. There was no formation of blood clots that could lead to blockage on the lower part inside the venous filter. The venous filter and the defoamer were fixed with physiological saline solution containing a glutaraldehyde solution, and then inspected under electron microscope. Adhesion of blood cell components such as red blood cells and platelets and formation of fibrin net were observed. There was no formation of blood clots that could lead to blockage on the lower part inside the venous filter. A part of the venous filter was cleaned, and then inspected under electron microscope. No anomaly was observed in the filter condition, such as uneven mesh diameter. Reproductive testing was performed, and bovine blood was circulated in the manner that air continued entering the venous line. As a result, it was confirmed that blood flowed out from the upper part of the venous filter. The air entering the venous filter is defoamed by the defoamer in the venous line in the normal condition. The reproductive test showed that, as the air continued entering the venous line, the defoamed blood flowed out from the upper part of the venous filter. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. It is likely that air continued to be drawn from the venous line, causing fluid to flow out from the upper side of the venous filter. In addition, it was conceivable that the air bubbles entered the venous filter may have agitated the blood activating the coagulation factors, which led to the formation of blood clots in the housing. 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 the capiox device was used during the procedure. The patient underwent mvp/tap/maze mics. Air from venous line was observed immediately after the start of extracorporeal circulation, although it disappeared soon. About ten minutes after the start of ecc, a holdup phenomenon occurred on the venous side of the reservoir. The reservoir level was 1000 ml, and the fluid was lifted up to the position of defoamer at 3500ml. There was no problem with the oxygenator pressure or the filter on the cr side. After that, when the fluid level moved, blood clots were observed on the fluid surface. They maintained the circulation without changing the level and prevented air entering from venous line. Once rewarming started from 32°c, the holdup phenomenon disappeared and the ecc was completed without any problem. After collecting blood, blood clots were found in the reservoir. The procedure outcome was not reported. The patient was not harmed.
 
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Brand NameCAPIOX FX25
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
mary o'neill
reg. no. 2243441
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key11884144
MDR Text Key265198218
Report Number9681834-2021-00086
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 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Catalogue NumberCX-XRX43502
Device Lot Number210129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2021
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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