MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problems Gas Output Problem (1266); Pressure Problem (3012)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

Implanted date: requested, not provided.Explanted date: requested, not provided.The actual device has not been received yet 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 had no anomaly found.No other similar reports of the product with the involved product code/lot number were found.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 oxygenator did not perform to its normal functionality, struggled to get the po2 above 80%.Two perfusionists were present during the case.They continued to use the oxy just adding more o2 with a portable o2 tank.They had a difficult time getting the po2 above 80% when warming.The surgery did not stop.The issue was mitigated by using a 02 tank.The event occurred during a cardiopulmonary bypass.There was no delay in the procedure.The product was not changed out.They continued to use the involved product and finished the case with it.However, they were unable to get the desired po2 while using it during the case.The patient was not harmed and not affected, and no blood loss was reported.The surgery was completed successfully.Additional information was received on 22 feb 2023: the procedure was a common av valve repair, takedown of the bidirectional glenn, and central aortopulmonary shunt.

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.The actual device has been returned for evaluation.Visual inspection of the actual sample upon receipt did not find any anomaly such as 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.It was confirmed to meet the factory's specifications: bovine blood conditions hb: 12g/dl, temperature: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg.Circulation conditions: blood flow rate: 2l/ minute and 1l/ minute, v/q:1, fio2: 100%.O2 transfer volume at 2l/ minute: 130ml/ minute, at 1l/ minute: 69ml/ minute.Co2 removal volume at 2l/ minute: 103ml/minute, at 1l/ minute: 59ml/ minute.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot number.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly were found in the manufacturing records.As a possible cause of occurrence, the complaint described that "when warming they had a difficult time getting the po2 above 80%", it was inferred that since rewarming stimulated the patient's metabolism, oxygen consumption increased and svo2 decreased.However, the cause of this case could not be clarified from the investigation result.For your reference, the instructions for use (ifu): (capiox fx05) of ashitaka factory has the following warning and precaution.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.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16526786
• MDR Text Key: 311573248
• Report Number: 9681834-2023-00040
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350739087
• UDI-Public: 04987350739087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX05RWA
• Device Lot Number: 220608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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
• Patient Age: 7 MO
• Patient Sex: Female
• Patient Weight: 6 KG