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

Catalog Number	CX*FX25E
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code11 has been referenced in the conclusions section of h6.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.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.
Event or Problem Description
The user facility reported during a cardiopulmonary bypass they had a failure with the pump on the involved capiox oxygenator.They went on bypass and immediately saw no color change and the venous stats were dropping.They went off bypass within a minute of going on bypass, they initially thought the isoflurane was blocking the oxygen.They went on bypass and recirculated the blood for a few minutes and did a gas.The p02 was 56, they repeated it and the p02 only went up to 82.They decided it was the oxygenator and changed it out.They did a gas, and the p02 was over 800.There was a four-minute delay.There was no blood loss.The product was changed out and the surgery was completed successfully.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Visual inspection revealed no anomalies.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol: bovine blood arranged to (hb12.0 g/dl, temp.37oc., ph:7.4, svo2:65% and pvco2:45mmhg) was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flaw rate of 6l/min.And 4l/min.Result: o2 transfer: 6l/min.= 410ml/min.@4l/min.= 288ml/min.Co2 removal: @6l/min.= 335ml/min.@4l/min.= 246ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.During the gas transfer performance test, the color of the arterial blood was compared with that of the venous blood.The color of the arterial blood was confirmed to be brighter than that of the venous blood.A review of the device history record of the product code/lot# combination was conducted with no findings.The ifu for this product has the indications 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.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample, after having been rinsed, was the normal product with no issue in the gas transfer performance.From the available information, with no evaluation of the pump record, the cause of this complaint cannot be determined.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7645807
• Report Number: 9681834-2018-00120
• Device Sequence Number: 1651795
• Product Code: DTZ
• UDI-Device Identifier: 04987350701022
• UDI-Public: 04987350701022
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• 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
• Report Date (Section B): 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CX*FX25E
• Device Lot Number: 180301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other