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

Catalog Number ZZ*FX05REA

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The user facility reported that oxy did not fully oxygenate.The event occurred during a cardiopulmonary bypass.There was a 30 to 40 seconds delay in the procedure.The product was changed out and the surgery was completed successfully.The blood amount was 43ml.The sales rep states that after an hour or two on bypass, and after changing to an o2 tank, the oxy did not fully oxygenate.Oxy started off great (po2 of 62) only 9.%, but approximately two hours after there was a decline in oxygenation.Once ccp was changed out the oxy gases became acceptable.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.(b)(4).

Manufacturer Narrative

A1: patient identifier - requested, not provided.A2: age & date of birth - requested, not provided.A3: patient sex - requested, not provided.A4: weight - requested, not provided.A5: ethnicity - requested, not provided.A6: race: requested, not provided.B3: date of event: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.For this reason, investigation conclusions code 11 has been referenced in section h6.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 oxy did not fully oxygenate.The event occurred during a cardiopulmonary bypass.There was a 30 to 40 seconds delay in the procedure.The product was changed out and the surgery was completed successfully.The blood amount was 43ml.The sales rep states that after an hour or two on bypass, and after changing to an o2 tank, the oxy did not fully oxygenate.Oxy started off great (po2>690), but after maybe two hours there was a decline in oxygenation, even after changing to an o2 tank it was po2 of 62, only 93%.Once ccp was changed out the oxy gases became acceptable.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the completed investigation results and to report that follow up no.1 was reported but came back as duplicate report on march 14, 2022.Visual inspection upon receipt did not find a breakage or other anomalies that could lead to the low oxygenation performance.The actual sample after rinsed and dried was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, the obtained values were within the factory's control standards.[bovine blood conditions] hb:12g/dl, temp.: 37°c., ph:7.4, svo2:65%, pvco2: 45mmhg [circulation conditions] blood flow rate: 2l/min and 1l/min, v/q=1, fio2=100% [o2 transfer volume]@2l/min= 120 ml/min.@1l/min= 68 ml/min [co2 removal volume]@2l/min= 96 ml/min.@1l/min= 60 ml/min the color of venous and arterial blood during the gas exchange-performance test showed that the color of arterial blood was brighter red than that of venous blood.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.The investigation result showed that the gas exchange performance of the actual sample met the factory's control standards and there was no anomaly in the manufacturing- related records.Based on the provided information, it was possible that the patient's metabolism increased during rewarming, so the oxygen supply was insufficient for the patient's oxygen consumption, svo2 decreased, and pao2 decreased.Since the actual sample after cleaned was confirmed to have no anomaly, the cause of occurrence could not be clarified.For your reference, the ifu for capiox fx05 includes the following precaution.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13544246
• MDR Text Key: 288184643
• Report Number: 9681834-2022-00012
• Device Sequence Number: 1
• Product Code: DTZ
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: ZZ*FX05REA
• Device Lot Number: 210211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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): Required Intervention
• Patient Age: 18 MO
• Patient Sex: Female
• Patient Weight: 7 KG