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

Catalog Number CX-FX15RW40

Device Problem Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was received at the manufacturing facility for evaluation.Visual inspection revealed no anomalies or defects.Saline solution was let to flow through the actual sample by gravity and the actual sample was subjected to another visual inspection.No visible formation of thrombus was found inside the oxygenator.The actual sample, after having been rinsed and dried was tested for its gas transfer performance.Bovine blood was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the blood flow rates of 5l/min.And 3l/min.The obtained values met manufacturing specification.A review of the perfusion record from the involved procedure obtained the following information: the circulation was started at fio2=70% and it was, thereafter, gradually increased.Po2 always stayed around 200mmhg.A review of the manufacturing record of the product code/lot number 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.An exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported insufficient gas exchange in the capiox device.Follow up communication with the user facility confirmed the following information: scheduled operation of (avr + cabg).The pao2 value was already low immediately after the initiation of the circulation.Fio2 was increased each time after the blood examination but pao2 always stayed around 200 and with this value, the customer decided not to change out the actual sample.The case was completed successfully.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6136322
• MDR Text Key: 61244954
• Report Number: 9681834-2016-00275
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CX-FX15RW40
• Device Lot Number: 160604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BLOOD CIRCUIT (MEDTRONIC); REVOLUTION CENTRIFUGAL PUMP (SORIN)
• Patient Weight: 48