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

Catalog Number CX-FX15W

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual device was returned for evaluation.Visual inspection revealed that the purge line tube connected to the oxygenator module had a crack at approximately 11 cm from the purge port on the oxygenator module.Saline solution was let to flow by gravity drop.It leaked from the crack on the purge line tube.Magnifying inspection of the crack on the purge line tube found that the crack had been generated by being compressed from both sides.The actual sample was set on the factory-retained holder.It was found that the crack on the purge line tube was located at the same level as the table to be used to set the sampling system on it.Reproductive testing was performed on a factory-retained oxygenator module and was set on the holder and the purge line tube was let to be pinched by the table and the arm components (movable components).A crack which was like that on the actual sample was duplicated on the purge line tube.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings.The ifu states: warning: do not use an oxygenator that leaks.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation, it is likely that the purge line tube of the actual sample was subjected to some pinching force and got cracked, resulting in the reported leak.However, based off the available information the exact cause of the reported event cannot be definitively determined.(b)(4).

Event Description

The user facility reported that the actual capiox sample leaked during priming.The customer found that the purge line tube had a crack.The event occurred pre-treatment.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8679246
• MDR Text Key: 147568083
• Report Number: 9681834-2019-00095
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CX-FX15W
• Device Lot Number: 181214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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