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 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The actual device was discarded by the user facility, therefore the investigation was limited to the information provided by the user facility and evaluation of the retention sample from the reported product code/lot number combination.Visual inspection confirmed the retention sample had no anomalies which would relate to the reported leak.The retention sample was built into a circuit and colored saline solution was circulated through it.No leak was confirmed.A review of the device history record and product release decision control sheet 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.There is no evidence this event was related to a device defect or malfunction.The retention sample confirmed to be normal product with no anomalies which would relate to a leak.The exact cause of the reported event cannot be definitively determined.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 use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Do not use an oxygenator that leaks.Replace it with another capiox rx25 oxygenator.(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: there was a leak observed in the oxygenator ports during priming; and there was no patient involvement.

Manufacturer Narrative

This report is being submitted as follow up number 1 to provide the codes.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 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: 6876594
• MDR Text Key: 87747429
• Report Number: 9681834-2017-00200
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: (01)04987350769572(17)200131(10)170207
• 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,Followup
• Report Date: 09/19/2017

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: 01/31/2020
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 170207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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