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

Catalog Number CX-FX25RW

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The 510k - k130520.The actual device along with the thermistor code was returned for evaluation.Visual inspection revealed no anomalies.The actual device was rinsed and dried.The thermistor probe and thermistor code were inspected fluoroscopically under x-ray; revealing no anomalies were found.The response of the actual device to a temperature was compared with that of the retention sample, revealing no unstable condition in temperature.The connection of the thermistor probe of the actual device and the thermistor code provided by the customer was removed little by little.No variation occurred in the temperature values.When the terminal was completely removed, the determination of temperature ceased.The thermistor probe of the actual device was connected to the thermistor code provided by the customer again.The thermistor code was subjected bending force.No variation occurred in the temperature values.A review of the pump record noted some up-and-down movements in the arterial and venous temperatures, indicating that the temperatures were unstable.There was no correlation between the temperature and the blood flow rate.Based on the information in the pump record, saline solution @ approximately 24 oc was circulated in the blood phase for three hours.Subsequently, the temperature of the saline solution was elevated up to 37oc and the circulation was continued for another 3 hours.During the circulation, the temperature was monitored with a capiox centrifugal pump controller sp-200(neo).During this test no unstable condition in temperature was observed.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed there were no indication of production related anomalies.There is no evidence that this event was related to a device defect or malfunction.During the investigation, the reported unstable values in the temperature were not duplicated.(b)(4).

Event Description

The user facility reported while using the capiox device during priming and bypass, the temperature of the arterial blood was unstable.The procedure outcome and patient impact was reported to be unknown.A cardiovascular system s5 (livanova) was used.

• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7391731
• MDR Text Key: 104536670
• Report Number: 9681834-2018-00036
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: CX-FX25RW
• Device Lot Number: 171227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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