MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05 HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1CX*FX05RE

Device Problems Excessive Cooling (2932); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned to the manufacturing facility for evaluation and the lot number is unknown.Therefore, the investigation was based upon evaluation of user facility information and testing of a product sample.A fx05 oxygenator sample was built into a circuit at the room temperature of 20 degrees celsius.The 500 ml of saline solution was put into the whole body of the circuit.With the circulation of hot water at 37 degrees celsius in the heat exchanger, saline solution was circulated in the main circuit at the flow rate of 1.5 l/min.Then the circulation in the main circuit was stopped.It was noted, approximately 40 seconds later, the temperature was determined with the thermistor probe set at the venous blood inlet port decreased by approximately 2 degrees celsius.The temperature was determined at the blood outlet port on the oxygenator module also decreased with a time difference.A fx05 oxygenator sample was built into a circuit at the room temperature of 20 degrees celsius 500 ml of saline solution was put into the whole body of the circuit.With the circulation of hot water at 37 degrees celsius in the heat exchanger, saline solution was circulated in the main circuit at the flow rate of 1.5 l/min.Then the flow rate in the main circuit was reduced to 0.1 l/min.It was noted, approximately three minutes later, the temperature was determined at the venous blood inlet port had decreased by approximately 2 degrees celsius.There was little change in the temperature determined at the blood outlet port on the oxygenator module.Based on the investigation results, it is likely that the fluid contained in the circuit became cooled down by the room temperature.The exact cause of the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure.However, there is no indication that the reported event was related to a product defect or malfunction.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.(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 an issue with the accuracy of the venous temperature measurement during cardiopulmonary bypass.Follow up communication with the user facility confirmed the following information: when weaning from cpb, the venous inlet temperature measurement drops up to 2 degrees c from pre-wean full flow temperature measurement; the product was not changed out; the surgery was completed successfully; and it was reported there were no patient issues.

• Brand Name: CAPIOX FX05 HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: 6036173
• MDR Text Key: 57693555
• Report Number: 9681834-2016-00243
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1CX*FX05RE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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