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

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.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, 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 Key: 6184928
• MDR Text Key: 62690330
• Report Number: 9681834-2016-00294
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• 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 Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2019
• Device Catalogue Number: ZZ*FX25RW
• Device Lot Number: 160324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial