MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF

Catalog Number 1CX*FX25E

Device Problem Failure to Prime (1492)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Udi - the udi is not required for the reported product code/lot number combination, however the di portion was provided.The actual device has not been returned to the manufacturing facility for evaluation.For this reason, (b)(4) was used in the conclusions section.A follow up report will be submitted within 30 days of this report being sent.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.(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 that the capiox device failed to prime during setup.Follow up communication with the user facility confirmed the following information; the locked volume out of the bottom vent would not prime; it would prime during normosol; the product was changed out; the procedure was completed successfully; and there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information about the device return in device available for evaluation?.The actual device is not available for evaluation.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) is referenced.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the retention sample evaluation results, provide the entire udi no.& the expiration date.The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of user facility information and a retention sample of the involved product code/lot number combination.Visual inspection of the retention sample revealed no defects.Functional testing was conducted and could not duplicate the reported event.The investigation verified that the retention sample was the normal product.During the inspection, the reported event was not duplicated.With the absence of the actual sample to be evaluated, the cause of this complaint cannot be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Manufacturer Narrative

This report is being submitted as follow up number 3 to provide the returned sample evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies.The actual sample was filled with saline solution.With the blood outlet port clamped and pressure applied to the blood pathway from the blood inlet port side for 6 hours.No leak was confirmed.The water pathway of the heat exchanger module was filled with water.With the water outlet port clamped pressure was applied to the water pathway of the heat exchanger module from the water inlet port side for 6 hours.No leak was confirmed.The actual sample was built into a circuit with tubes.Saline solution colored for better visibility was let to flow into the circuit little by little.As a result, the reported complaint could not be duplicated.There is no evidence that this event was related to a device defect or malfunction.The actual sample was confirmed to be normal product.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENATOR
• 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: 6310339
• MDR Text Key: 66777531
• Report Number: 9681834-2017-00007
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1CX*FX25E
• Device Lot Number: 160721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1