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

Catalog Number	CX*RX05RW
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted g5: 510(k): k122590 the involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample from the involved product code/lot# combination.Visual inspection revealed there were no anomalies, such as a break, in the appearance.The sample was tested for its gas transfer performance in accordance with the manufacturer shipping inspection protocol.Bovine blood arranged to hb12.0 g/dl, temperature 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 flow rate of 2l/min.And 1/min.The following results were found: o2 transfer: @2l/min.= 118ml/min.@1l/min.= 68ml/min.Co2 removal: @2l/min.= 97ml/min.@1l/min.= 57ml/min.No anomalies were revealed in the gas transfer performance of the retention sample, with the obtained values meeting the manufacturer specifications.A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.Ifu states: 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.This investigation results verified the retention sample was of the normal product.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.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 that the perfusionist changed out the capiox oxygenator; after initiating the bypass initial po2 was 250, and after thirty minutes po2 dropped down to 45 mmhg.The procedure outcome and patient outcome was unknown.Blood loss was not reported.

• 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: 8458989
• Report Number: 9681834-2019-00043
• Device Sequence Number: 2978048
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: 04987350763471
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K022115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 08/31/2021
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 180912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2019
• Initial Report FDA Received Date: 03/28/2019
• 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