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

Catalog Number CX-XRY27301

Device Problems Coagulation in Device or Device Ingredient (1096); Leak/Splash (1354)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-clinical engineer.Pma/510(k)- k130520.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 judgement record of the involved product code/lot# combination was conducted with no findings.The involved fiber lot had been subjected to the shipping inspections, which includes gas-transfer performance test and pressure-drop test.The test results were confirmed to meet the factory's control criteria.There was no anomaly noted in them.Ifu states: do not use this product for a period in the excess of six hours.Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance.It is likely that due to a change in the blood properties, a surface-active substance may be generated in blood.This may lead the balance of the surface tension between the gas and blood, which has been kept at the micro pores on the surface of the fibers, to be upset, and the fibers got hydrophilized, resulting in plasma leak; the pressure inside the oxygenator module raised by some factors, such as clotting, may cause the pressure applied from the blood pathway to the gas pathway to get increased.This may create the circumstances where force to push the blood corpuscle components out into the gas phase may increase and plasma component could easily leak out through the micro pores on the surface of the fibers to the gas pathway.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported the capiox custom pack was used during the procedure.During cardiac surgery operation, when pumping time exceeded six hours, protamine was administered at the end.At the timing when the contents of the reservoir started to coagulate, a leak from the oxygenator was found.Something looked like blood was mixed in the gas line.When the leak occurred, priming was still being performed for the re-pump just in case.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX CUSTOM PACK
• 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; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 11512202
• MDR Text Key: 261953080
• Report Number: 9681834-2021-00028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CX-XRY27301
• Device Lot Number: 191203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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