MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 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 05/12/2023

Event Type  Injury  

Event Description

The user facility reported that the involved capiox device plasma leak occurred 7 hours after circulation started.The leak continued until the patient was separated from the circulation.The case was an intraoperative dissection, occurred during the operation for a valve replacement (artificial vessel replacement).Circulation time was 8 hours (with hemolysis).Patient complications were colorectal cancer, hyperlipidemia, hypertension, diabetes, syphilis (+).The arterial temperature before and after the leak was 36°c.Drugs that were administered were bicanate, mannitol, sublood, haptoglobin, voluven, solu-medrol, and neo-synesin.Blood transfusion amount was 12 units of rbc was administered one (1) hour after circulation started, 10 units of ffp was administered five (5) hours after circulation started and then administration continued.The product was used while the plasma leak continued.The procedure outcome was successfully completed.The event occurred intra-operative.The final patient impact was not harmed.The patient was not injured during the event and medical or surgical intervention was not required.

Manufacturer Narrative

E3: occupation: clinical engineer g4: 510(k) no: k071494, k130520 the actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The manufacturing record and the shipping inspection record of the actual product was conducted, no anomaly was found.Past complaint file was reviewed, no other similar report of the product with the involved product code/lot # were found.Based on the investigation result, no anomaly was found in the manufacturing record of the actual product.As a possible cause of occurrence, from our experience, following factors were inferred.However, since the actual sample could not be investigated, it was not possible to clarify the cause of plasma leak.The blood properties changed due to some factor, a substance having a surface-active action was produced, and the relationship between the surface tension of blood and gas maintained in the micropores of fiber was broken.This made the fibers hydrophilic, leading to plasma leak.Due to the increase in the pressure inside the circuit (e.G., during the formation of blood clot), the pressure applied from the blood channel to the gas channel increased.As a result, the force for blood components to flow out to the gas channel increased, leading to plasma leak.Relevant instructions for use (ifu) reference: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.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.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).

• Brand Name: CAPIOX CUSTOM PACK
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17102115
• MDR Text Key: 316951236
• Report Number: 9681834-2023-00105
• 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: 06/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX54021
• Device Lot Number: 221129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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
• Treatment: ADMINISTERED DRUGS: BICANATE, MANNITOL, SUBLOOD.; HAPTOGLOBIN, VOLUVEN, SOLU-MEDROL, NEO-SYNESIN.