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

Catalog Number CX*RX25RW

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Visual inspection revealed no anomalies.The actual sample was built into a circuit with tubes and colored saline solution was circulated in it, while being observed for any leak.No leak was confirmed.The oxygenator module was filled with saline solution.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port.No leak was confirmed.Magnifying inspection of the joint of the sampling line tube with the port on the oxygenator module did not reveal any anomaly, including a crack.Electron microscopic inspection of the joint of the sampling line tube with the port on the oxygenator module did not reveal any anomaly, including a crack or defective insertion of the tube to the port.A review of the manufacturing record and shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample was of the normal product without any crack which would lead to a leak.(b)(4).

Event Description

The user facility reported they found a crack between the blood sampling tube and the artery port when they opened the capiox package.There was no patient involvement, the event occurred pre-treatment.

• Brand Name: CAPIOX RX 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: 7560754
• MDR Text Key: 109905115
• Report Number: 9681834-2018-00093
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 180208C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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