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

Catalog Number CX-XRX07002

Device Problem Insufficient Heating (1287)

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

Event Date 12/10/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.A review of the device history record and the product release decision control sheet of the involved product/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.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a defective heat exchanger in the capiox device.Follow up communication with the user facility confirmed the following information: the actual sample was used for total arch replacement surgery for the acute aortic dissection treatment; the patient's rectal temperature was around 27° c; at the final stage of the procedure, rewarming started; despite that the temperature of the heater-cooler unit was set to 41° c, the patient's temperature reached only 31° c; the temperature cable and the heater-cooler unit were changed out; no change in the patient's temperature yet; the rewarming was assisted by blood being circulated in the cardioplegia circuit of which temperature had been set to 40° c at 500ml/min.Then being returned to the reservoir; while the rewarming temperature at the actual sample was kept at 41° c the procedure continued; and finally the rectal temperature was raised up to around 36° c.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the returned sample evaluation results.Visual inspection of the actual sample upon receipt revealed no defects.Saline solution was let to flow into the actual sample by gravity, while the oxygenator module was observed with the unaided eye for any presence of clotting.No clot was revealed.Visual inspection of the thermistor probe revealed no defects.A temperature sensor cable was connected to the thermistor probe on the actual sample and the temperature was determined while saline solution at 41 degrees c was circulated in the actual sample.The obtained temperature value was confirmed to meet manufacturer specification.The investigation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason code was used in the conclusions.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the returned sample evaluation results.The actual sample, after having been rinsed and dried, was evaluated for its heat exchanging performance in accordance with the factory's heat exchanging performance test protocol.The heat exchanging effectiveness of the actual sample was determined by letting bovine blood flow through the actual sample in one-way direction while water was being circulated in the actual sample.The obtained test results verified that the actual sample's heat exchanging performance meets the manufacturing specification.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.The exact cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "use the upper port for water supply and the lower part for water drainage.Otherwise heat exchange will not be performed sufficiently." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

• 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: 6237903
• MDR Text Key: 64432701
• Report Number: 9681834-2016-00302
• 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,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: CX-XRX07002
• Device Lot Number: 160801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: SORIN-HEATER COOLER UNIT; SORIN-S5 ROLLER PUMP; SORIN-SECOND HEATER COOLER UNIT
• Patient Weight: 62