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

Catalog Number CX*FX25RW

Device Problem Increase in Pressure (1491)

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

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

The actual device has not yet been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason (b)(4) was used in the conclusions section of evaluation codes.The production lot number was not provided by the user facility which prevented a meaningful review of production and complaint records.(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 pressure increase in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: the pressure increased in the capiox device to 470 mmhg; afterwards the pressure was 120 mmhg; the flow was 4.6 l/min.; the oxygenator was replaced with other terumo product without any complications; there was no significant delay in the procedure; there was no blood lost; treatment was executed as planned; the patient was treated as intended; the patient recovered from the reported serious injury; and the user reported this event to (b)(6) as follows: for an aorta valve inspection the patient was connected to the heart lung machine (12:14 h start time).During the perfusion (12:50) the pressure before oxygenator started to increase without noticeable reason, the system was exchanged at 12:59.Before perfusion began the act was 526s.At oxygenator exchange the act was 606s.The exchange led to circulatory arrest of 57 seconds, with a body temperature of 32°c.The exchange happened by routine and trouble-free.

Manufacturer Narrative

This report is being submitted as follow up number 1 to provide the actual device evaluation results as well as the lot number, expiration date and manufacturing date.Visual inspection found no obvious anomalies in the appearance of the device.The actual device was rinsed, dried and subjected to another visual inspection.It was confirmed not to have any anomalies.The actual device was built into a circuit.Bovine blood @hct35% and temp.37°c was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturing specifications.Bovine blood was kept circulated in the actual device for 6 hours.No obstruction occurred.When the circulation was ceased, the actual device was flushed with water.No clot was found inside the actual device.The perfusion record was reviewed.At 12:14 the circulation was initiated.At 12:50 the inlet pressure increased.At 12:59, the actual oxygenator was changed out.At the initiation of the circulation no increase in the pressure was noted.From this, it is assumable clots formed during the circulation and the oxygenator was obstructed, resulting in the reported high pressure.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found one other report of this nature from the same user facility with the involved product code/lot number combination.See mdr 9681834-2017-00173.There is no evidence this event was related to a device defect or malfunction.The investigation result verified the actual device was the normal product.The exact cause of the reported event cannot be definitively determined based on the available information.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.All available information has been placed on file in quality assurance at the manufacturing facility 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6773960
• MDR Text Key: 82053184
• Report Number: 9681834-2017-00170
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 141031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 75