MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX05 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, unknown.A2: age: requested, unknown.A5: ethnicity: requested, unknown.A6: race: requested, unknown.D4: lot number: cx*fx05rea/ d4: udi: (b)(4).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: unknown.G4: pma/510(k): k130280.The actual sample was not returned to ashitaka factory.In this case, since the involved product/lot number was reported as fx05/220512, the involved product code was estimated to be "cx*fx05re" or "cx*fx05rea," and the investigation was carried out as follows.Review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly.A search of the past complaint file found no other similar complaint regarding the involved product code/lot were not reported.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.As for the cause of this incident, it was not possible to clarify it because the actual sample could not be confirmed, and detailed information was unknown.Relevant instructions for use (ifu) reference: "start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements." "measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.-to decrease pao2, decrease fio2.-to increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.-to decrease paco2, increase total gas flow.-to increase paco2, decrease total gas flow." "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." "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 5 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the capiox oxygenator involved had low oxygenation, the costumer verified all connections, and all was fine.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.No health hazards were reported at the time the information was obtained.

• Brand Name: CAPIOX FX05 OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16831489
• Report Number: 9681834-2023-00076
• Device Sequence Number: 11226437
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 220512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 12 KG