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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-XRZ23001
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2019
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Establishment name: (b)(6) hospital 510(k): k130280. The device was returned for evaluation. Visual inspection upon receipt found a substance white in color adhering to the inside wall on the graduation side. There was not any obvious anomaly, such as a break, in the appearance. The actual device was disassembled and the foreign substance white in color was collected. Sem-edx (scanning electron microscope - energy dispersive x-ray spectrometry) elementary analysis of the foreign substance detected some elements constituting organic substances, including nitrogen and sulfur. Ft-ir (fourier transform infrared spectroscopy) qualitative analysis of the foreign substance obtained the spectrum of protein. The cardiotomy filter and the defoamer taken out of the cardiotomy filter, after having been rinsed in physiological saline solution, were subjected to visual inspection. The presence of clots was noted on the defoamer. Based on the investigation, the foreign substance white in color adhering to the inside wall of the actual sample was found to be protein derived from a living body. Some clots were found to have formed on the defoamer of the cardiotomy filter. There is no evidence that this event was related to a device defect or malfunction. Based on the investigation result, it is likely when blood in which coagulation factors has been activated flows into the reservoir and stayed on the solution level, clots may start to form there. 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 that during the circulation, the customer found a foreign substance white in color, which he thought was a white thrombus, adhering to the inside wall of the reservoir on the area around the graduation of 600ml. The customer completed the procedure successfully without changing out the actual sample and there was no blood loss or 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
mark vornheder
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
MDR Report Key8435518
MDR Text Key139454157
Report Number9681834-2019-00026
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
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 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberCX-XRZ23001
Device Lot Number181023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2018
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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