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

Model Number	N/A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: requested, not provided.Explanted date: requested, not provided.Initial reporter country: palestine.Initial reporter telephone number: (b)(6).Initial reporter occupation: perfusionist.Pma/510(k) - k130280.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file found no other similar indications regarding the involved product code/lot.The actual sampled was discarded by the involved facility.Since the actual sample was not returned, investigation of it could not be performed.According to the investigation result, no anomaly was found in the manufacturing records.From the additional information that the gas line was connected correctly to the oxygenator, as a cause of the dark blood observed during priming, a possibility was considered that the blood was not oxygenated due to some factors.However, it was not possible to confirm the actual sample, and the cause could not be clarified.Ifu states: "measure blood gases and make necessary adjustments as follows.(d.During perfusion) a.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported technical issues in a procedure for atrioventricular (av) canal disease on a cardiopulmonary bypass machine, and during the priming with blood before the surgery as a routine we note a dark blood in the priming.They replaced the oxygenator immediately.The gas flow was turned on and the gas line was connected to oxygenator correctly.The priming composition was normal saline (ns)/red blood cells (rbc)/fresh frozen plasma (ffp).A blood gas was performed.The po2 of the blood was analyzed to validate and was po2 30%.The perfusionist put the oxygenator on heparin formula.The procedure outcome was not reported.The patient was not harmed.It is unknown if there were any other devices or equipment used with the reported product.

• Brand Name: CAPIOX FX05 OXYGENATOR
• Common Device Name: 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16513599
• Report Number: 9681834-2023-00038
• Device Sequence Number: 15055631
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 220112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown