MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	1CX*FX05RE
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason code 11 was used in the conclusions section of h6.A review of the device history record and product release decision control sheets of the involved product/lot# combination was conducted with no relevant findings.A search of the complaint file found no report with the involved product code/lot# combination.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.H3 other text : device not returned to manufacturer.
Event or Problem Description
The user facility reported insufficient gas exchange in the capiox device.Follow up communication with the user facility confirmed the following information: pao2 was lower than expected and paco2 was higher than expected in the first 10 minutes of cardiopulmonary bypass; it was reported that the product was not changed out; surgery was completed successfully; and there was no patient injury.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update on the status of this report.The device has been received by the manufacturer and is currently under evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.Device is currently under evaluation.
Additional Manufacturer Narrative
The actual device was returned to the manufacturer for evaluation.Visual inspection upon receipt found no anomalies which would relate to a gas leak or insufficient gas transfer performance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance to the factory's shipping inspection protocol: bovine blood was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flaw rate of 2l/min.And 1l/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.The investigation result verified that the actual sample, after having been rinsed and dried, was the normal product with no issues.Based upon the additional information, it is likely the fio2 was low and the v/q ratio was small.However, there is no indication that the reported event was related to a device defect or malfunction.The ifu of this product does have the instruction as follows: start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.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 following additional information was reported: at the initiation of the extracorporeal circulation, the blood flow rate was 1.2l/min., the gas flow rate was 0.3l/min with fio2= 70%; in a few minutes after the circulation the color of blood became dark.The blood gas analysis found pao2 was around 100mmhg abd paco2 was around 90mmhg; fio2 was increased to 100% with the gas flow rate of 1.5l/min., pao2 reached around 300mmhg and paco2 around 50mmhg.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5611503
• Report Number: 9681834-2016-00109
• Device Sequence Number: 23381
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2016

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: 04/30/2018
• Device Catalogue Number: 1CX*FX05RE
• Device Lot Number: 150520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 05/25/2016; 06/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1