MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/19/2021

Event Type  Injury  

Event Description

The user facility reported that the capiox device was used during the procedure.After the start of emergency surgery for aortic dissection, o2 concentration on the arterial side did not increase during rewarming.It returned to normal once the patient was cooled; however, when the temperature was raised again, the o2 concentration on the arterial side tended not to increase.The oxygenator in question was changed out.The patient was not harmed.The procedure was completed successfully.

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-clinical engineer.Pma/510(k)- k130280.The actual sample was received for evaluation.Visual inspection revealed no breakage or other anomaly in the appearance.The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually.Formation of blood clots was not observed.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 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: 6l/min and 4l/min, v/q=1, fio2=100%.[o2 transfer volume] @6l/min= 387 ml/min.@4l/min= 277 ml/min.[co2 removal volume] @6l/min= 311 ml/min.@4l/min= 228 ml/min review of the provided pump record revealed: rewarming started at 18:02 and at 20:08.From 18:02, when rewarming started, until 18:51, pao2 continued to decrease down to 140 mmhg.At 19:19, it was found to have increased to 336 mmhg.At 19:19, the set temperature was 23.0°c.From this, it was presumed that cooling was performed from 18:51 to 19:19.- from 20:08, when rewarming started, until 20:55, pao2 continued to decrease down to 213 mmhg, at 21:03, pao2 was found to have increased to 355 mmhg.From this, it was presumed that the oxygenator in question was changed out at some point between 20:55 and 21:03.Gas flow rate and fio2 were not mentioned thus not confirmed.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: 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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.The reason for the lack of increase in the o2 concentration on the arterial side during rewarming may have been that the patient's metabolism was activated by the rewarming, which increased the oxygen requirement, resulting in a decrease in svo2 and a decrease in pao2.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

• Brand Name: CAPIOX FX25 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12785965
• MDR Text Key: 284646290
• Report Number: 9681834-2021-00196
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX25E
• Device Lot Number: 210603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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