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

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

The user facility reported that the capiox oxygenator involved was used in an extracorporeal circulation operation at ordinary temperature for a patient with a re-operation (bsa: approx.1.5, target index: 2.5).Quadrox was used at the beginning of the operation.However, it became difficult for the co2 value to decrease on the way, so it was replaced with a fx15e.A little while after the replacement, it became difficult for the co2 value to decrease even with fx15, and even if it circulated at 3l or more, it did not improve significantly.Nevertheless, the surgery was successfully completed.(act: 1000 seconds or more, fx15 usage time: approx.50 minutes) the final impact of the patient was not harmed.Medical or surgical intervention was not required.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was returned for investigation.Visual inspection of the actual sample did not find any anomaly including a breakage that could lead to gas transfer failure.After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure manual.It was confirmed to meet the factory's specifications and no anomaly was found in the gas transfer performance.[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg.[circulation conditions] blood flow rate: 5l/min and 3l/min, v/q:1, fio2: 100%.[o2 transfer volume] @5l/min: 301ml/min., @3l/min: 200ml/min.[co2 removal volume] @5l/min: 248ml/min., @3l/min: 171ml/min.Review of the manufacturing history record and the product release decision control sheet of the actual sample confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.Based on the investigation result, no anomaly was found in the gas transfer performance of actual sample after rinsing and drying.As a cause of occurrence, it was likely that since the pco2 of the blood flowing into the oxygenator was high for some reason, paco2 was also high.However, it was not possible to identify the cause of the increase in pco2 of the blood flowing into the oxygenator from the state of actual sample.Relevant ifu reference: measure blood gases and make necessary adjustments as follows: control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.(d.During perfusion).(b)(4).

• Brand Name: CAPIOX FX OXYGENATOR
• 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: stephanie handy ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 14414102
• MDR Text Key: 292357947
• Report Number: 9681834-2022-00088
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-FX15E
• Device Lot Number: 201012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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