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

Catalog Number CX-FX15RE40V

Device Problem Gas Output Problem (1266)

Patient Problem Diminished Pulse Pressure (2606)

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device wasnt explanted.Occupation - clinical engineer.Pma/510(k)- k071494, k130520.The actual device has been returned for evaluation.Visual inspection upon receipt did not find a breakage or other anomaly in the appearance, which could lead to low gas exchange performance.The actual sample after rinsed and dried was tested for its gas exchange performance in accordance with the factory's inspection protocol.As a result, the obtained values met the factory specifications, and no anomalies were revealed.[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= 306 ml/min.@3l/min= 204 ml/min.[co2 removal volume]@5l/min= 241 ml/min.@3l/min= 165 ml/min.Review of the provided pump record obtained the following findings: (i) circulation started (0:00) with blood flow rate: 3.95l/min, gas flow rate: 2.0l/min, fio2: 60%, and arterial blood temperature: 34.6°c; (ii) 0:05, paco2 was 42.6 mmhg, pao2 was 172 mmhg; (iii) 0:30, paco2 increased to 55.2 mmhg and pao2 dropped to 84 mmhg; (iv) 0:35, gas flow rate and fio2 were increased to 4.0l/min and 80% respectively, 0:65, fio2 was increased to 100%; (v) 0:70, paco2 54.1mmhg, pao245.7mmhg, 0:72, paco2 55.8mmhg, pao2: 40.1mmhg; (vi) although gas flow rate and fio2 had been increased, paco2 had increased and pao2 had dropped.After the second oxygenator was added at 0:74, pao2 was found to have increased to 585 mmhg (exact time of measurement was unknown).Review of the manufacturing record and the product-release judgement record of the involved product/lot number combination confirmed there was no anomaly in them.A search of the complaint file found no similar report with the involved product code/lot number combination.From the investigation results, no anomaly was found in the gas exchange performance of the actual sample after rinsed and dried.The reason for the poor oxygenation performance was presumed that the contact between blood and gas might have been obstructed due to some factors, or the low pao2 could have meant that arterial and venous blood could have been measured incorrectly, however, the cause of occurrence could not be clarified.Relevant ifu (instructions for use) 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).

Event Description

The user facility reported that the during an emergency operation the oxygenation status was observed carefully from the beginning due to bad condition of the patient.In 30 minutes from circulation started, spo2 and pao2 decreased.Despite coping this by lowering temperature, no improvement was achieved, therefore, in 73 minutes another fx15 was added, as a results, the oxygenation performance was recovered.Pressure drops of the device in question, which was measured before the second oxy was added, was normal around 40 - 50 mmhg (act 800 - 1100), so the cause of the decline in oxygenation could not be identified.Coped with adding the second fx15.Medical or surgical intervention was not required to prevent injury or blood loss.The event occurred intra-operative.The patients final impact was not harmed.

• 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; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15130616
• MDR Text Key: 304812137
• Report Number: 9681834-2022-00151
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX15RE40V
• Device Lot Number: 211215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 66 KG