MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Gas Output Problem (1266)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

Implanted date: requested, not provided.Explanted date: requested, not provided.Occupation: perfusionist.Pma/510(k): k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The manufacturing record and the shipping inspection record of the actual product, no anomaly was found.Past complaint file, no other similar report of the product with the involved product code/lot#: was found.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of (b)(4) corporation (manufacturer) registration no: (b)(4).

Event Description

The user facility reported an oxygenating chamber failure, sudden decline in gas exchange performance, replacement of the device in emergency, in cardioplegic arrest during pediatric cardiac surgery.Used for circulating endothelial cells (cec).During the warm-up phase during aortic clamping at 197 minutes of cec a sudden dark coloration of the arterial blood was noted and immediately carrying out a blood gas test with the following values with fio2 at 100% and medical air 8 lt/minute with blood flow 3, 5 l/minute: pao2 36.9 mmhg, pco2 48.1 mmhg.Given the po2 /fio2 values, it was decided to immediately replace the device with a livanova inspire 8f oxygenator and continue the cec until the end of the procedure.The replacement of the oxygenator lasted about 5 minutes with a blood loss of about 300 ml.The patient is currently in the intensive care, in mechanical ventilatory support, performed a negative neurological window.Operation: reoperation on the ascending aortic duct with replacement of the same + mitral valve.It was malfunctioning due to gas transfer failure.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.H6: investigation findings - 114 is based upon the evaluation of user facility information; 213 is based upon functional testing of the returned sample.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information; 67 is based upon functional testing of the returned sample.Investigation of the actual sample: visual inspection of the actual sample upon receipt: no anomaly such as a breakage that could lead to gas transfer failure was found.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.It was confirmed to meet the factory's specifications.No anomaly was found.[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: 317ml/min., @3l/min: 203ml/min.[co2 removal volume] @5l/min: 248ml/min., @3l/min: 166ml/min.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found in the manufacturing records.As a possible cause of this case, from additional information that oxygenation was low "during the warm-up phase", it was inferred that since the patient's metabolism was activated by rewarming, the oxygen supply amount was insufficient for the patient's oxygen consumption, and svo2 decreased.However, since no anomaly was found in the actual sample, it was not possible to clarify the cause of occurrence.Ifu states:"measure blood gases and make necessary adjustments as follows.A.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).Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing in patients metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed ot the amount of the patient's gaseous metabolism.(precaution)".Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX15 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16340278
• MDR Text Key: 309264525
• Report Number: 9681834-2023-00011
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 210416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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 Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 51 KG