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

Catalog Number CX-FX15RE40

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested but not provided.Age and date of birth - requested but not provided.Sex - requested but not provided.Weight - requested but not provided.Ethnicity - requested but not provided.Race - requested but not provided.Udi number for this product code is not required.The actual device was returned for evaluation.Visual inspection of the thermistor probe revealed no defects.The actual device was rinsed and dried.The temperature sensor cable which was provided by the involved customer was connected to the thermistor probe of the actual device.Then saline solution, with the initial temperature set to 8 degrees celsius, was circulated in the blood phase.While the saline solution was being warmed up in the constant-temperature bath of which temperature was set to 38 degrees celsius and the temperature of the saline solution was increasing, the temperature of the saline solution was determined with the actual thermistor probe and at the same time with a factory-retained thermistor probe for comparison.The temperatures obtained from the two thermistor probes were confirmed to be equivalent to each other.During this circulation, the reported indication of the single digits in the temperature was not duplicated.After the above test, saline solution at approximately 38 degrees celsius was circulated for another 1 hour and then its temperature was determined while it was stable with the actual thermistor probe and at the same time with a factory-retained thermistor probe for comparison.The temperatures obtained from the two thermistor probes were confirmed to be equivalent to each other.During this circulation, the reported indication of the single digits in the temperature was not duplicated.After the above test, 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, then the determination of temperature ceased.During this test the reported indication of the single digits in the temperature was not duplicated.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.During the investigation, the reported indication of the single digits in the temperature was never duplicated.The actual sample, after having been rinsed and dried, was the normal product.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the thermistor probe on the capiox device was found to be defective.Follow up communication with the user facility confirmed the following information: the values of the determined arterial temperature were extremely unstable.It was reported that sometimes it went down to the single digits.There was no harm to the patient.The procedure outcome is unknown.

• 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: 7120406
• MDR Text Key: 95081944
• Report Number: 9681834-2017-00247
• 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: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: CX-FX15RE40
• Device Lot Number: 170801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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