MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX15 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that they had a cabg case on cpb.Priming with 500ml gelofusine, heparin 5000 unit 350ml mannitol (10%) and 100ml hartman's.Initiate cpb with act more than 1000 sec (flow 4.5lpm, fio2 100%, gas sweep 2.5l.On cpb, abg shows pao2 - 63mmhg and paco2 421mmhg.When increase gas sweep to 5l, repeat abg shows pao2 - 69mmhg.Test with o2 tank 100% still no changes.Patient reported to be safe.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: unknown.G4: 510k #: k130520.1.Investigation of the actual sample: 1.1 visual inspection of the actual sample upon receipt · no anomaly such as a breakage was found.1.2 after rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure.It was confirmed to meet the factory's specifications.No anomaly was found.[bovine blood conditions] hb: 12g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg [circulation conditions] blood flow rate: 5l/min and 3l/min, v/q:1, fio2: 100%.[o2 transfer volume] @5l/min: 304ml/min., @3l/min: 201ml/min.[co2 removal volume] @5l/min: 243ml/min., @3l/min: 165ml/min.2.Record review: 2.1 the manufacturing record and the shipping inspection record of the actual sample · no anomaly was found.2.2 past complaint file: · no other similar report of the product with the involved product code/lot# was found.2.3 manufacturing date: october 18, 2023.3.Cause of occurrence/conclusion: based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found in the manufacturing records.As a possible cause of occurrence, from the information "flow 4.5lpm, fio2 100%, gas sweep 2.5l", it was inferred that the performance of fx15-sized oxygenator was insufficient for the patient's oxygen consumption, and the oxygen supply was insufficient.However, since no anomaly was found in the actual sample, the cause of this case could not be clarified.Relevant ifu reference: capiox fx15 is designed to operate at blood flow rates within the range of 0.5 to 5.0 l/min.Do not use any blood flow rate outside this range.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.(b)(4) (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX15 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 ; 4103927218
• MDR Report Key: 18843154
• Report Number: 9681834-2024-00029
• Device Sequence Number: 15537076
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: 04987350701169
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K071494
• 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): 03/05/2024

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 231018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GELOFUSINE; HARTMAN'S; HEPARIN; MANNITOL (10%)
• Patient Sex: Unknown