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

Catalog Number CX-XRX15310

Device Problem Pressure Problem (3012)

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

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection of the actual device found no visible anomalies in the appearance.The pressure drop was determined while saline solution was being circulated in the blood pathway at each flow rate.The obtained values were found to be higher than those obtained from the current product sample.After the test, the actual device was inspected with the naked eye for its appearance.Some clots were found to have formed inside the device.It is, however, difficult to determine when they formed, whether during the actual use or during transportation back to (b)(4) factory.The actual device was rinsed and dried.The pressure drop was determined at each flow rate while bovine blood was circulated in the blood pathway.The obtained values were confirmed to meet manufacturer specifications.A review of the device history record of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.There is no evidence this event was related to a device defect or malfunction.The investigation above verified that the actual device, after having been rinsed, was the normal product without any deficiency which could have been a trigger for the reported increase in the pressure drop.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.(b)(4).

Event Description

The user facility reported an increase in the pressure drop in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: recirculation was required after cpb.The actual sample, however, was found to have become unusable for recirculation possibly due to clotting.The whole system was changed out to a new one.It was reported that the amount of blood loss is unknown.No known patient impact.

• 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: 7013117
• MDR Text Key: 91438883
• Report Number: 9681834-2017-00234
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: CX-XRX15310
• Device Lot Number: 170822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• 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
• Treatment: A RR40 RESERVOIR; SORIN REVOLUTION CENTRIFUGAL PUMP
• Patient Outcome(s): Other