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

Model Number	CX*RX05RW
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported poor oxygenation.It was replaced with a new rx05; however, the oxygenation did not improve.The event occurred intra-operative.There was no patient injury or medical/surgical intervention required.There was no health hazard attributable to the event.The procedure outcome was not reported.The final patient impact was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: 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 e1: establishment name: unknown e3: occupation: clinical engineer visual inspection of the actual sample upon receipt found no anomaly such as a breakage.The actual sample, after rinsed and dried, was tested for the o2 transfer and co2 removal performance in accordance with the product inspection protocol.It was confirmed to meet the factory's specifications.No anomaly was found.[bovine blood conditions] hb: 12 g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45 mmhg [circulation conditions] blood flow rate: 2 l/min and 1 l/min, v/q:1, fio2: 100% [o2 transfer volume] @2l/min: 116 ml/min., @1l/min: 65 ml/min [co2 removal volume] @2l/min: 99 ml/min., @1l/min: 57 ml/min review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly.Search of the past complaint file of the involved product code/lot# found no other similar report was found.Based on the investigation result, the gas transfer performance of the actual sample after cleaning met the factory's specifications, and no anomaly was found.Since no anomaly was found in the actual sample, the cause of occurrence could not be clarified.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." "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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction.D4: udi.The udi was updated to match the correct format.Due to internal review, a correction was made to section d3.

• Brand Name: CAPIOX®RX
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, MD 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 ; 4103927218
• MDR Report Key: 18193346
• Report Number: 9681834-2023-00227
• Device Sequence Number: 20509071
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: (01)04987350763471(17)260331(10)230421
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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
• Device Expiration Date: 03/31/2026
• Device Model Number: CX*RX05RW
• Device Catalogue Number: N/A
• Device Lot Number: 230421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2023
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 08/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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
• Patient Sex: Male