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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 OXYGENATOR OXYGENTOR

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TERUMO CORPORATION, ASHITAKA CAPIOX RX15 OXYGENATOR OXYGENTOR Back to Search Results
Catalog Number CX*RX15RE40
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2015
Event Type  malfunction  
Manufacturer Narrative
This section was completed by the manufacturer per cfr 803. 52(f) (11) because the information was not initially completed by the user facility. The actual device has been received but the evaluation is not yet complete. A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent. (b)(4). A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings. A search of the complaint file found no report of this nature with the involved product/lot# combination. Terumo medical corporation (tmc) (importer) (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) (b)(4). All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported breakage in the capiox rx15 device. Follow up communication with the user facility confirmed the following information: (1) the perfusionist requested an oxygenator; (2) the personnel in the surgery department opened the box that the oxygenator came in and gave the oxygenator to the perfusionist; (3) without opening the bag that the oxygenator came in the perfusionist could see that the oxygenator was not adjusted with the venous reservoir and would not receive the device; and (4) there was no patient involvement.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 for mfg. Report no. 9681834-2015-00275 to provide the sample evaluation results. The actual device was returned to the manufacturing facility for evaluation. Visual inspection confirmed the customer's complaint. In the state of being packaged in the unopened peel pack, the oxygenator module and the supportive arm were noted to have come off each other. Visual inspection inside of the peel pack found that the two clips to fix the oxygenator module and the supportive arm had come off their places. The oxygenator module was unpacked and subjected to visual inspection. The gas out port was found to have been deformed with the generation of some scratches on the housing component. Visual inspection of the peel pack found it had some perforated holes. Magnifying inspection of the two clips which had come off found that the claw parts had been damaged. The oxygenator module and the supportive arm were reconnected. Neither component was observed to have a deformity which would prevent them from being joined to each other securely. There is no evidence that this event was related to a device defect or malfunction. The exact cause cannot be determined based on the available information. Based on the investigation results, it is likely that the actual sample was subjected to a shock force, such as a dropping force, due to inattentive handling of the product during transportation. The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e. G. Cracked) or any of the port caps are off. " all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Event Description
This report is being submitted as follow up no. 1 for mfg. Report no. 9681834-2015-00275 to provide the sample evaluation results.
 
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Brand NameCAPIOX RX15 OXYGENATOR
Type of DeviceOXYGENTOR
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
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key5353128
MDR Text Key35736956
Report Number9681834-2015-00275
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K051997
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 01/05/2016,01/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue NumberCX*RX15RE40
Device Lot Number150313
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/05/2016
Device Age9 MO
Event Location No Information
Date Report to Manufacturer01/05/2016
Date Manufacturer Received01/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2015
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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