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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. The actual sample was received for evaluation. Visual inspection revealed that the lock adapter had been come off from the male connector of sampling system. The lock adapter that was come off was not returned. Magnifying inspection of the actual sample did not find any anomaly including a deformation on the male connector. The outer diameter of the rib of actual male connector was measured and was compared with its factory-retained product. No difference was found. The surface of actual male connector was elementally analyzed by sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy). As a result, si was detected, which was likely to be derived from the silicone applied to the cock of the three-way stopcock for the purpose of improving lubricity. Simulation test: as a simulation test, after applying silicone to the male connector of a factory-retained sampling system, the female connector was connected, and applied torque force to the lock adapter. As a result, it was found that the lock adapter was come off. Product structure: the sampling system is designed so that the internal step of lock adapter is caught on the rib of male connector so that it will not loosen when fitted with the female lure. Therefore, if the rib is completely overcome for some reason, the fitting may come off. 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 since the silicone applied to the cock of sampling system for the purpose of improving lubricity was transferred to the male connector for some reason, it came off when the lock adapter was tightened. However, from the state of the actual sample, it was not possible to clarify when the silicone was transferred to the male connector. 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 Key12891647
MDR Text Key282278868
Report Number9681834-2021-00211
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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