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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX42352
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Address- (b)(6) medical center. Occupation- clinical engineer. Pma/510(k)- k130520. The actual sample was received for evaluation. Visual inspection of the actual sample confirmed that the lock adapter had come off the male connector of the sampling system. Magnifying inspection of the actual sample did not find any visible anomaly, including deformity, in the male connector or in the lock adapter. The outer diameter of the rib of the male connector and the inner diameter of the lock adapter were measured. Compared to a current product sample, no difference was observed in the measured values. The surface of the male connector was subjected to elemental analysis by sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy). The result showed the presence of si, which is likely to be derived from the silicone applied to the switch cocks of the three-way stopcock to improve the lubricity of them in the manufacturing process. Simulation test: silicone was applied to a male connector of a factory-retained sampling system, a female connector was attached to it, and then a lock adapter was tightened up. As a result, the lock adapter came off the male connector. Product structure: the sampling system is designed so that the internal step of the lock adapter is hooked on the male connector's ribs to prevent loosening when the female luer is connected. Therefore, if the internal step completely overcomes the ribs for some reason, the mating may come off. A review of the device history record and product-release judgement record 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 is likely that the silicon, which is applied to the switch cocks of the sampling system to improve the lubricity, was transferred to the male connector part due to some factors; therefore, it was likely that the lock adapter came off when it was re-tightened. However, from the available information including the state of the actual sample, it could not be determined when 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 custom pack was used pre-treatment. There was dislodgement of the luer lock of the sampling system. It appeared to have occurred during priming. Instead, they used the existing single three-way stopcocks by connecting them together. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX CUSTOM PACK
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 Key12655445
MDR Text Key277477453
Report Number9681834-2021-00183
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 10/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-XRX42352
Device Lot Number210603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
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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