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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 ZZ*FX25RW
Device Problem Failure to Prime (1492)
Patient Problem No Patient Involvement (2645)
Event Date 11/22/2016
Event Type  malfunction  
Manufacturer Narrative
This product code is a bulk item and the udi is not required. Results: based on evaluation of user facility information & the returned photograph; based upon evaluation of the returned actual sample. Conclusion: is based upon evaluation of user facility information & the returned photograph; based upon evaluation of the returned actual sample. The actual device and a photograph has been returned to the manufacturing facility for evaluation. The photograph inspection confirmed the reported complaint. There were some air bubbles staying at two points on the upper area of the oxygenator module. Visual inspection of the actual device revealed no anomalies or defects. The actual sample was rinsed, dried and filled with saline solution. With the blood-outside clamped, a pressure of 2. 0kgf/cm2 was applied from the blood-in side for 6 hours. No leak occurred. The actual sample was rinsed and dried again. It was then built into a circuit with tubes and primed in accordance with manufacturer specification. Neither entrainment of air or backflow of air from the purge line occurred. Functional testing was conducted. Abrupt priming of the actual sample at the flow rate of 7l/min. Caused some air bubbles to remain inside the oxygenator module while the prime was flowing into the oxygenator module. These bubbles were found to be difficult to remove when the circulation flow rate was insufficient. 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 did not find any other report with the involved product code/lot# combination. There is no evidence that this event was related to a device defect or malfunction. The results of the investigation verified that the actual sample was normal product. (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 they were unable to prime the capiox device. Follow up communication with the user facility confirmed the following information: air appeared on top of the oxygenator just before going on bypass and could not be removed; the oxygenator was replaced and perfusion commenced as normal; and there was no patient involvement.
 
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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
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6184928
MDR Text Key62690330
Report Number9681834-2016-00294
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberZZ*FX25RW
Device Lot Number160324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2016
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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