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

Catalog Number CX*FX25RW

Device Problem Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned to the manufacturing facility and the investigation is currently ongoing.A follow up will be sent within 30 days of this report being sent.A review of the device history record and the product release decision control sheet confirmed that there is no indication of production-related problem or of discrepancy in the test/inspection results.A search of the complaint file found no other report of this nature with the involved product/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 fx25 oxygenator shut down.Additional details have been requested.

Manufacturer Narrative

This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2015-00195 to provide the return sample evaluation results as well as to update sections report type, type of reportable event.Follow up communication with the user facility confirmed that there was no patient involvement.With no patient involvement the report type is no longer classified as adverse and has been updated to reflect a product problem.Considered a malfunction, (b)(4).The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt did not find any obvious anomalies in the appearance.The actual sample was rinsed and dried and subjected to another visual inspection.No anomaly in the appearance was revealed.The actual sample was built into a circuit with tubes and bovine blood was circulated in it at each flow rate, while the pressure drop was determined and confirmed to meet manufacturing specifications.The actual sample was confirmed not to have any occlusion that may lead a pressure rise in the circuit.A review of the manufacturing record of the involved product /lot# combination confirmed that there were no indications of production-related problems.There were no nonconforming indications in the shipping inspection record of the involved product /lot# combination.A search of the complaint file did not find any other report with the involved product/lot# combination.The exact cause of the complaint cannot be determined based on the available information, however a potential cause of the reported blocking in the oxygenator could have been thrombus formation.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation, otherwise, blood clotting might occur." all available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).

Event Description

This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2015-00195 to provide the return sample evaluation results as well as to update report type, type of reportable event.Follow up communication with the user facility confirmed that there was no patient involvement.With no patient involvement the report type is no longer classified as adverse and has been updated to reflect a product problem in.Section now considered a malfunction, (b)(4).

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENTOR
• 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: kathleen little ; reg. no. 2243441; 2101 cottontail ln.; summerset, NJ 08873 ; 8002837866
• MDR Report Key: 5055814
• MDR Text Key: 24988859
• Report Number: 9681834-2015-00195
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/14/2015,09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 150402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/14/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2015
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2015
• 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
• Patient Outcome(s): Other