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

Catalog Number CX-XRX00660

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Address: (b)(6) hospital.Occupation: clinical engineer.Pma/510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed that the fiber on the gas inlet port and gas outlet port had decolored in red.There was not any breakage in the visible range.The gas channel was blown with air.As a result, liquid was flown out from the gas outlet port side.The liquid was tested with protein test paper ("uriace"), and the presence of protein was confirmed.In addition, the collected liquid was centrifuged.As a result, no precipitation of blood cell components was observed.Therefore, it was considered that the plasma component leaked due to hydrophilization of the fiber.After the actual sample was rinsed, the blood channel was filled with physiological saline solution, and then the blood outlet port was occluded, and air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port.As a result, no leak occurred.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Review of the shipping inspection record of the product in which the involved fiber lot was used confirmed that there was no anomaly in the gas exchange performance test and pressure drop test results.The test results satisfied the factory's control criteria.Review of the pump record could not find any factor that could lead to a plasma leak.Ifu states: a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Start gas supply with v/q=1 and fio2=100%, then make adjustments based on blood gas measurements.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.A plasma leak was likely to have occurred in the actual sample, it was likely that the cause of the decrease in po2 during the circulation was that the plasma leak hindered the contact between blood and oxygen gas, resulting in a decrease in gas exchange performance.It is likely that the plasma leak may have been 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 is 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 channel to the gas channel 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 channel.However, 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 custom pack was used during the procedure.When the major blood vessel operation exceeded four hours, the o2 dropped after de-clamping.The oxygenator was changed out.The o2 did not increase while fio2 was increased to 100%.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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 10596336
• MDR Text Key: 209352561
• Report Number: 9681834-2020-00194
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CX-XRX00660
• Device Lot Number: 200527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• 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