MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 1CX*FX05RW

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted. Explanted date: device was not explanted. 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. 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. This report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2020-00093. (b)(4).

Event Description

The user facility reported that the involved capiox hemoconcentrator clotted off during cardiopulmonary bypass. There was no delay with the procedure due to the event. Surgery was completed successfully with little loss of blood (under 100 cc's). Due to both hemo and oxy clotted, the patient was asked if they had any underlying issue and they said no; however, they did give donor blood. The patient was reported to be fine. It started up with the hemoconcentrator, it clogged up and was changed out before going on bypass. When they were trying to go on bypass, the oxygenator clotted off. They changed out he oxygenator and the reservoir. All throughout the case, they noticed a huge buildup of clot form in the venous sat. There was no injury to the patient.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: 10111054
• MDR Text Key: 193427377
• Report Number: 9681834-2020-00092
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1CX*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 200124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/02/2020 Patient Sequence Number: 1