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

Catalog Number	CX*RX25RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: telephone number did not fit properly in designated section.Phone no.: (b)(6).The actual device has been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted on the investigation is complete.For this reason code 20 was used in the conclusions section of h6.A review of the device history records and product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported the capiox device leaked.Follow up communication reported the following information: the perfusionist conducted the occlusion setting and calibration, prior to the start of bypass cardiopulmonary; the drop level was observed to be incorrect; the perfusionist tried to verify the leak in the tubing, but no leak was noted; the actual device was changed out; and there was no patient involvement.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the returned sample investigation results.The actual sample was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies which could have led to a leak.The roller pump tube used in combination with the actual sample was not provided for evaluation.The oxygenator module, after having been separated from the circuit, was filled with saline solution.With the blood outlet port clamped, an air pressure was applied to the blood phase from the blood inlet port for 6 hours.No leak was observed.Subsequently, the water phase of the heat exchanger module was filled with water.With the water outlet port clamped, an air pressure was applied to the water phase of the heat exchanger module from the water inlet port for 6 hours.No leak was observed.The actual sample was built into the actual circuit with a terumo's roller pump tube added to the circuit.Saline solution colored for better visibility was filled in the circuit.After the occlusion of the roller pump was adequately adjusted, the fluid level in the tube downstream the oxygenator module was positioned higher than the fluid level of the reservoir.A significant drop in the fluid level did not occur in the tube downstream the oxygenator.The abnormal drop level reported by the customer was not duplicated.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample was 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 RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6492940
• Report Number: 9681834-2017-00073
• Device Sequence Number: 19239334
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: (01)04987350769558(17)181130(10)151201
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 151201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1