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

Catalog Number	CX*RX25RE
Medical Device Problem Code	Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was received at the manufacturing facility for evaluation.Visual inspection 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.The obtained values met manufacturing specification.Confirmation testing confirmed that the pao2 determined on the actual sample was higher than that determined during the actual use.A comment was made by the user facility that several similar incidences has happened over the past three months.However, those events were not reported to the manufacturer and no additional information was available including event dates, product codes, patient information or any specific event descriptions.Therefore, because it is not possible to conduct meaningful investigations or obtain sufficient information about the individual events, we are including this anecdotal information within this report for reference purposes.A review of the device history record and the product release decision control sheet of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the actual sample was the normal product with no issue in the gas transfer performance.An 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.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 insufficient gas exchange in the capiox device.Follow up communication with the user facility confirmed the following information: the oxygenator was used in a case where the patient was receiving cardiac surgery.The perfusionist reported that the device wasn´t efficiently oxygenating during that specific case in the cardiac surgery.There have been similar cases over the last three (3) months.There was no patient harm.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6122744
• Report Number: 9681834-2016-00260
• Device Sequence Number: 162213
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• 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
• Report Date (Section B): 11/22/2016

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: 10/31/2018
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 151128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82