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

Catalog Number CX-FX25REV

Device Problem Gas Output Problem (1266)

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

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: requested, not provided, age & date of birth: requested, not provided, patient sex: requested, not provided, weight: requested, not provided, ethnicity: requested, not provided, race: requested, not provided, udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted, explanted date: device was not explanted, occupation - clinical engineer, pma/510(k) - k071572, k130280.The actual sample was received for investigation.Visual inspection of the actual sample found that liquid had been accumulated in the housing of gas channel, and that the cross section of fiber had been discolored in red.No anomaly including a breakage that could lead to gas transfer failure was found.Air was supplied into the gas channel of actual sample.As a result, bubbly liquid outflow was found.This liquid was confirmed with a factory-retained protein test paper (uriace) and found that it contained protein.Therefore, this fluid was likely to be plasma.However, it was not possible to clarify when this fiber became hydrophilic (at the time of use, at the time of return).After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured using bovine blood.It was confirmed to meet the control standard values in the factory's specifications and no anomaly was found in the gas transfer performance.Bovine blood conditions- hb: 12g/dl, temperature: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg.Circulation conditions - blood flow rate: 6l/minute and 4l/minute, v/q:1, fio2: 100%.O2 transfer volume at 6l/minute: 379ml/minute, at 4l/minute, 275ml/minute.Co2 removal volume at 6l/minute: 322ml/minute, at 4l/minute, 232ml/minute.Review of the manufacturing history record and the shipping inspection record of the actual sample confirmed that there were not any indications of 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 investigation result, no abnormality was found in the gas transfer performance of the actual sample after rinsing.As a cause of occurrence of this case, from the investigation result of actual sample and the information during rewarming, following factors were inferred.However, the cause of occurrence could not be clarified.It was inferred that rewarming stimulated the patient's metabolism.Therefore, the amount of oxygen supplied did not catch up with the patient's oxygen consumption, and svo2 and pao2 decreased.It was inferred that the fiber was hydrophobized (plasma leak occurred) for some reason.Due to this, the contact between blood and gas was hindered, resulting in a decrease in gas transfer performance.From our past experience, as the cause of plasma leak in the actual sample, it was inferred that due to some change in blood properties, a substance with a surface-active action was produced, and the relationship between the surface tension of blood and gas maintained in the micropores on the fiber surface was broken.Therefore, plasma leak was likely to occur.Relevant ifu (instructions for use) reference: 1) upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patients 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.2) a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 9681834-2022-00197.(b)(4).

Event Description

The user facility reported that the involved capiox device oxygenator was replaced, due to gas transfer failure during rewarming.However, the replaced device also had a gas transfer failure.Weaning was done.The patient was not injured during the event and medical or surgical intervention was not required.The patient final impact was not harmed.The event occurred intra-operative.No patient harm resulting from this incident was reported.Serious injury as the product was replaced during blood circulation.

• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15581967
• MDR Text Key: 301558637
• Report Number: 9681834-2022-00196
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX25REV
• Device Lot Number: 220427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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 Outcome(s): Required Intervention