MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX25RW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematuria (2558)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k) - k130280.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings.Review of the shipping inspection record of the involved fiber lot confirmed that the gas transfer performance test and pressure drop test results met the manufacturer control criteria and no anomaly was noted.It is likely that post-operative hematuria urine appeared because hemolysis might have occurred due to some factors.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during the procedure.Post-operative hematuria urine was found when the patient was transferred from the operating table to his bed.During the bypass the urine is small; however, clear.The bypass lasted 2 hours and 28 minutes without any particular concern except for some unexplained hemodynamic problems (variation of blood pressure) transmitted to the anesthetist.Probable hemolysis.The patient impact and procedure outcome were not reported.

• Brand Name: CAPIOX FX25 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: 10307923
• MDR Text Key: 199864292
• Report Number: 9681834-2020-00137
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: ZZ*FX25RW
• Device Lot Number: 190705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2019
• 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 Outcome(s): Other