MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier requested, not provided date of birth requested, not provided ethnicity requested, not provided race requested, not provided implanted date: device was not implanted explanted date: device was not explanted pma/510(k)- k130520 the actual sample was received for evaluation; a reservoir, an oxygenator, and two clips.Visual inspection revealed that the oxygenator module was found to have come off the supporter arm.Visual inspection of the connector part of the support arm on the reservoir did not find any anomaly such as deformity or break in the appearance.Visual inspection of the support arm connectors on the oxygenator found that they had been deformed partially.Visual and magnifying inspection of the two clips found the pawls had been deformed.Visual inspection of the plastic bag found creases and holes in it.Reproductive testing was performed, and a factory-retained product sample contained in a unit box was dropped by gravity from 1.5 m-high.The oxygenator module did not come off the support arm, a factory-retained product sample contained in a unit box was dropped by gravity from 3.5 m-high.The oxygenator module came off the support arm.A review of the device history record product release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the deformed clips, broken plastic bag, and the reproductive test results, as a cause of this complaint, it is likely that the actual sample was exposed to significant shock force beyond the product strength during transportation or storage.However, the exact cause of the reported event cannot be definitively determined based on the available information, including the state of the returned actual samples.Terumo medical products (tmp) (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (b)(4).

Event Description

The user facility reported that the involved capiox rx25 was used pre-treatment.There was separation of joint between the reservoir and the oxygenator.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX RX25 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 ; 2837866718
• MDR Report Key: 10269760
• MDR Text Key: 241833241
• Report Number: 9681834-2020-00111
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 191227C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2019
• 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 Age: 44 YR
• Patient Weight: 48