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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*FX25RE
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k)-k130520. The actual sample was received for evaluation. Visual and magnifying inspections of the actual l-shaped female connector found that the tip flange had been damaged. No anomaly including a deformation was found in other sections. Visual inspection of the male connector on the side of the actual sampling system did not find any anomaly including a breakage. Magnifying inspection of the lock adapter on the side of the actual sampling system found that the screw thread had been deformed. Electron microscopic inspection of the damaged surface of the actual l-shaped female connector found that the fracture surface was smooth and streaky marks were observed at an edge of fracture. Therefore, it was inferred that the fracture occurred due to the force applied in the direction from the flange end to the inside. Simulation test: as a simulation test, the following confirmation was carried out assuming a situation where force is applied from the flange end to the inside. After connecting the l-shaped female connector to the factory-retained sampling system, the lock adapter was tightened strongly. As a result, the lock adapter slipped, and the flange damage was not simulated. After connecting the l-shaped female connector to the factory-retained sampling system, pushing force was applied to the l-shaped connector. As a result, the male and female connectors were tightly fitted so that no force was applied to the flange and the damage was not simulated. After connecting the l-shaped female connector to the factory-retained sampling system, pulling force was applied. As a result, damage was found on the tip flange of the l-shaped female connector. Electron microscopic inspection of the damaged surface of factory-retained damaged product found that the damaged surface was smooth and was similar to the actual sample. A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no findings. Ifu states: do not use if the package or device is damaged (e. G. Cracked) or any of the port caps are off. 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 was likely that force in the pulling direction was applied to the l-shaped female connector from the time the product was installed at ashitaka factory to the time it was used and was damaged. However, from the state of the actual sample, it was not possible to clarify when it was damaged. 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 the capiox device connector of sample line could not be fixed, easy to dis-connect during the priming. The event occurred pre-treatment, the patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX FX OXYGENATOR
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
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key12891797
MDR Text Key282278613
Report Number9681834-2021-00212
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25RE
Device Lot Number210324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2021
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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