MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RW

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- requested, not provided. 510(k) - k130280. The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. For a review of the device history record and the product release judgement control record of the involved product code/lot number combination revealed no findings. (b)(4).

Event Description

The user facility reported that the involved capiox device was used during the procedure. Surgical management of patient with regular tetralogy of fallot with persistent ductus arteriosus and hyper pulmonary flow in the context of poly malformative syndrome. At the time of the operation, a leak was observed at the outlet of the oxygenator from the extracorporeal circulation. They plugged the leak to successfully complete the operation. Risk of hypovolemia; patient blood loss was bout 70ml. There was no harm to the patient.

• Brand Name: CAPIOX FX05
• 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; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 10156896
• MDR Text Key: 197351114
• Report Number: 9681834-2020-00094
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 181031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial