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

Catalog Number CX-XRX37501

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection of the thermistor probe found no obvious anomalies.Visual inspection of the oxygenator module found no obvious anomalies.Simulation testing was conducted.The actual sample was rinsed and dried.A temperature sensor cable was connected to the thermistor probe of the actual device.The temperature was determined while saline solution was being circulated in the actual device.The obtained temperature values were confirmed to meet manufacturing specifications.The reported unstable state in the arterial temperatures with incorrect value display was not duplicated.The terminal of the temperature sensor cable connected to the thermistor probe of the actual device was removed little by little.No variation occurred in the temperature values.Consequently, the terminal was completely removed, when the determination of temperature ceased.During this test variation in the values never occurred.Based on the assumption that some solution had adhered to the connection between the terminal of the temperature sensor cable and the thermistor probe of the actual device, distilled water was put to the connection.No variation occurred in the temperature values.The customer's complaint could not be duplicated.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot number combination.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample was normal product.Simulation testing conducted on the actual sample did not duplicate the customer's complaint.The actual cause of the reported event cannot be definitively determined.(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 an unstable arterial temp on the capiox device during a procedure.Follow up communication with the user facility reported the following information: during the extracorporeal circulation, the customer noticed that the arterial temperature was unstable, showing temperatures between 14 -20°c, which were lower than the actual temperature.The temperature sensor cable was changed out with no improvement.The procedure was continued to the end with no change out of the actual device.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 6544967
• MDR Text Key: 74501066
• Report Number: 9681834-2017-00089
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CX-XRX37501
• Device Lot Number: 161007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• 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