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

Catalog Number CX*RX25RW

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was discarded by the involved facility.Therefore, a factory retained sample from the reported product code/lot number combination was evaluated.Visual inspection confirmed the retention sample had no anomalies.Leak tests were conducted.The blood pathway of the sample was filled with saline solution with the blood outlet port side clamped.The inside of the blood pathway was pressurized with an air of 2kgf/cm2 applied from the blood inlet port side.No leak was confirmed.The water pathway of the heat exchanger module was filled with water.The water outlet port side was clamped.The inside of the water pathway of the heat exchanger module was pressurized with air of 3kgf/cm2 applied from the water inlet port side.No leak was confirmed.A review of the device history record and shipping inspection record from the reported product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lo number combination.The investigation verified the retention sample was the normal product.With no returned of the actual device 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; warning: do not use an oxygenator that leaks.(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 a leak in the capiox device prior to a procedure.Follow up communication with the user facility confirmed the following information: after priming the cpb circuit a leak was noted; the leak was found before the initiation of cardiopulmonary bypass; leak of priming fluid was seen in the gas outlet as well as in gas inlet; and there was no patient involvement.

• 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: 6940272
• MDR Text Key: 90291511
• Report Number: 9681834-2017-00211
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)200331(10)170428
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K040210
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 170428
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• 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