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

Catalog Number CX*RX25RW

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The actual sample was received for evaluation.Visual inspection revealed that the actual sample was contained in an unopened original sterile bag and the support arm had come off the oxygenator module.The original sterile bag had been torn on the section that had contact with the support arm.The actual sample was taken out of the sterile bag for closer visual inspection.There was no deformity or no break in the joint parts on neither the support arm nor the oxygenator module.Visual inspection of the dislocated two clips, which had fixed the support arm and oxygenator, found that the claws had been deformed.Visual inspection found some abrasions on the lateral side of the reservoir and the backside of the oxygenator module.Reproductive testing was performed and a factory-retained oxygenator sample in the state of being packed in the unit-box was dropped from a height of 1.5m with each side of the box facing the ground (6-time drops).Subsequently, the unit-box was opened for inspection of the oxygenator packed inside it.The test result showed that the support arm was confirmed to be in place on the oxygenator with no damage generated on the unit-box.A factory-retained oxygenator sample in the state of being packed in the unit-box was dropped from a height of 3.5m with each side of the box facing the ground (6-time drops).Subsequently, the unit-box was opened for inspection of the oxygenator packed inside it.The test result showed that the support arm was found to have come off the oxygenator with some damage generated on the unit-box.The damage similar to that on the actual sample was duplicated.The actual sample was found that its oxygenator module had come off the support arm.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sample was exposed to some shock force beyond the strength limit of this product during transportation or storage.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the capiox cardiotomy reservoir detached from the oxygenator, due to the bonding clip that came off from the oxygenator.It happened before bypass; during bypass circuit setup.They used another rx25 oxygenator from stock to manage that case.There was no patient involved.

• Brand Name: CAPIOX RX 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 9289605
• MDR Text Key: 219784247
• Report Number: 9681834-2019-00187
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 170728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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
• Patient Outcome(s): Required Intervention