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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

Ud: n/a as this product code is not exported to the us market implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: clinical engineer.Pma/510(k): k130520.Visual inspection of the actual sample found that there was no anomaly such as a brakeage.The cross section of the fiber on the gas-in side and the gas-out side was discolored red.Gas was blown into the gas channel of the actual sample.Foam-like liquid flowed out from the gas-out side.The liquid was tested with our protein test paper ("uriace") and confirmed to contain protein.The liquid was centrifuged, and no sedimentation was observed.The liquid was subjected to a blood cell analyzer.The blood components (white blood cell, red blood cell, and platelet) in the liquid were confirmed to be below the measurement limit.From this, the liquid was thought to be blood plasma that had turned pale red due to hemolysis.After the actual sample was rinsed, the blood channel was filled with colored physiological saline solution.As no leakage was observed, it was thought that there was no cut thread of fiber in the actual sample.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file found no other similar report with the involved product code/lot number.From the results of the investigation, it was confirmed that there was no cut thread in the fiber and plasma leakage had occurred in the actual sample.As a cause of plasma leakage in the actual sample, from our past experience, the following factor was inferred.However, it was not possible to clarify the cause of plasma leakage.It was considered probable that some changes in blood properties caused the production of surfactant substances leading to a breakdown of the relationship between the surface tension of blood and gas retained in the micropores on the surface of the fiber, which resulted in a susceptibility to plasma leak.Relevant instructions for use (ifu) reference: "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 5 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." 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 that approximately 300 minutes after initiation of extracorporeal circulation, a plasma leak (yellow + pink) developed.At that time the po2 dropped to 110 and bladder temperature was 28 degrees.After that, superior vena cava (svc) dissection occurred.After it was treated, the pump was weaned off.Po2 at the time of weaning improved slightly.The oxygenator was not changed out.The priming solution was voluven, bicanate, mannitol, and heparin.Avr, mvr, and maze case.Bsa1.49 pump flow 3l min, index2.6l of gas flow at 100% of fio2.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact 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: gina digioia ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16023142
• MDR Text Key: 308381441
• Report Number: 9681834-2022-00258
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRY21904A
• Device Lot Number: 220525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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