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

Catalog Number ZZ*FX15RW40

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required.The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based on the evaluation of user facility information and evaluation of a retention sample from the reported product code/lot number combination.Visual inspection revealed no anomalies or defects.The sample was built into a circuit with tubes.Bovine blood was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet manufacturer specifications.Bovine blood was then circulated for six hours.No obstruction occurred.When the circulation was ceased, the actual sample was flushed with water.No clot was revealed which could have lead to an increase in the 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 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 results verified the retention sample was the normal product without any deficiency which could have been a trigger of 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: the pressure increased to 470 mmhg.The act was within the therapeutic range.Blood lost: possible but causality not detectable, platelets were administered.No replacement of the oxygenator took place.The platelet count dropped during this period from 301 x 10e9/l to 55 x 10e9/l.There was no impact to the patient.

• 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: 7009349
• MDR Text Key: 92515697
• Report Number: 9681834-2017-00235
• Device Sequence Number: 1
• Product Code: DTZ
• 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
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: ZZ*FX15RW40
• Device Lot Number: 161207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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
• Patient Age: 57 YR
• Patient Weight: 57