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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*FX05RE
Device Problems Complete Blockage (1094); Device Inoperable (1663); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation. Visual inspection found no obvious anomalies in the appearance. The actual device was rinsed, dried and subjected to another visual inspection. It was confirmed not to have any anomalies. The actual device was built into a circuit. Bovine blood hct35% and temperature 37°c was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to meet the manufacturing specifications. Bovine blood was kept circulated through the device for 6 hours. No obstruction occurred. When the circulation was ceased, the actual device was flushed with water. No clot was found inside the actual device. On september 22, 2017 it was noted this device was also the same device reported in mdr 681834-2017-00199. There is no evidence that this event was related to a device defect or malfunction. The investigation results verified the actual device after having been rinsed was the normal product presenting no issue relating to obstruction. While the exact cause of the reported event cannot be definitively determined based on the available information that the patient was in the state of being cooled down and there was no issue in the gas transfer performance at the initial stage, it is likely the cold agglutination occurred and caused temporal obstruction in the actual device. The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not reduce heparin during circulation. Otherwise, blood clotting might occur. Adequate heparinization of the blood is required to prevent it from clotting in the system. All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Manufacturer Narrative
(b)(4). The actual device has not yet been returned to the manufacturing facility for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. For this reason (b)(4) was used in the conclusions section of evaluation codes. A review of the device history record and shipping inspection record from the reported product code/lot number combination was conducted with no relevant findings. A search of the complaint file found one other report from the same user facility with the involved product code/lot number combination. See mdr 9681834-2017-00199. (b)(4). All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported a failure with the capiox device during a procedure. Follow up communication with the user facility confirmed the following information: a terumo baby fx oxygenator failure 5 minutes after extracorporeal circulation (ecc), with blockage / occlusion / collapse of arterial oxygenator output; at full ecc during patient cooling from 37 °c to 32°c (water from the cooling / heating unit circulating at 30°c), total venous drainage observed without any oxygenated blood flow from the oxygen; complete impossibility of returning oxygenated blood to the patient was observed; act (+/- 10 minutes before the event)
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434 sec. ; elective pediatric surgery to close cia + civ + debanding ap, cec machine - terumo system 1, gas monitoring online - cdi 500, dual - size tubes: 1/4 "- venous blood inlet, 3/16 "- venous blood outflow, 1/4 "- 3/16" - arterial pump, (b)(6) 2016 "- arterial blood outlet; checking the pre-bypass check list (service routine); preparation of priming (calculation according to the pediatric protocol of the service), and its circulation: o sodium bicarbonate, o mannitol 20%, or heparin, the fresh plasma, the plasma lyte; administered heparin and its control, act
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434 sec. ; entering into ecc: arterial cannula
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12 fr and venous: vcs
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12 fr and vci
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16 fr. Vent catheterization and cardioplegia, with respective control and expurgation, respectively; start of patient cooling from 37°c to 32°c; first 5 minutes of ecc, no problem; impact: interruption of blood flow at the oxygen outlet with a period of low cardiac output, approximately 5 minutes, until the arterial circulation restored again; and it was reported there was no harm to the patient.
 
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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
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6856505
MDR Text Key258103737
Report Number9681834-2017-00198
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberCX*FX05RE
Device Lot Number160705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/05/2016
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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