MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 10/25/2022

Event Type  malfunction  

Event Description

The user facility reported that there was low oxygenation and poor oxygenation during rewarming of the caipox device involved.The event occurred pre-treatment.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

Visual inspection of the actual sample upon receipt did not find any anomaly such as a breakage that could lead to poor oxygenation.The actual sample was rinsed and dried, and the amount of o2 transfer and co2 removal was measured following the product inspection protocol.The obtained values met 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: 6l/min and 4l/min, v/q:1, fio2: 100%.· [o2 transfer volume] @6l/min: 381ml/min, @4l/min: 270ml/min.· [co2 removal volume] @6l/min: 333ml/min., @4l/min: 241ml/min.No pump record was obtained.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 with the involved product code/lot number combination.Based on the results of the investigation, the gas transfer performance of the actual sample after rinsing met the factory's control standards, and no anomalies were found.From the available information, as for the cause of this incident, it was likely that the patient's metabolism increased during rewarming, which resulted in an insufficient oxygen supply with respect to the patient's oxygen consumption and decreasing po2.However, there was no anomaly in the gas transfer performance of the actual sample, and the cause could not be clarified.Relevant ifu reference: "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.(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 RX25 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 ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15851292
• MDR Text Key: 307996157
• Report Number: 9681834-2022-00232
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• 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*RX25RW
• Device Lot Number: 210406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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: 67 YR
• Patient Sex: Male