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

Catalog Number CX*FX05RW

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130280.The actual sample was not available for the investigation.The image provided of the actual product showed a formation of glue-like clots.The blood level was considered to have been at least 400 ml or more based on the wet state of the defoamer of venous filter.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu sates: adequate heparinization of the blood is required to prevent it from clotting in the system.The reservoir of this product is designed to stabilize the blood storage surface to make it easier to manage, on the other hand, blood is difficult to be agitated in the reservoir.Based on this characteristic and experience, it was likely that blood with activated coagulation factors flowed into the reservoir and stayed on the surface, leading to the formation of blood clots, and afterward, when the fluid level was lowered, the formation of clots was revealed.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the capiox device was used during the procedure and there was blood clotting.The product was checked, no abnormity was found.The operator found blood coagulation in the reservoir after ten mins of cpb.Act was over 500s before cpb start.The product was exchanged a new one.The patient was not harmed.The procedure outcome was not reported.

• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12056324
• MDR Text Key: 265815152
• Report Number: 9681834-2021-00114
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2021

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: 05/31/2023
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 200604C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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
• Patient Age: 1 YR
• Patient Weight: 5