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

Model Number N/A

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

Age: 2 years & 3 months.Ethnicity: requested, unknown.Race: requested, unknown.Lot number: cx*fx05re, cx*fx05rea.Udi: (b)(4).(b)(4).Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: unknown.Pma/510(k): k071572, k130280.The actual sample has been received.This preliminary report is based on the review of relevant records as follows.In this case, since the involved product/lot number were reported as fx05/220512, the involved product code was estimated to be cx*fx05re or cx*fx05rea, and the investigation was carried out.The manufacturing record and the shipping inspection record of the actual sample, no anomaly was found.Past complaint file of the involved product code/lot number, another similar complaint was received from the same facility.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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 Description

The user facility reported low oxygenation when the bypass circuit was assembled according to usual protocol, with monitoring with cdi550, terumo fx05 oxygenator.The patient was cannulated with the usual bicaval and aorta technique for a repair of a ventricular septal defect.From five (5) minutes after the start of the bypass did not present optimal po2 despite the use of 100% fi02, verification of oxygen connections, use of direct tank oxygen, the oxygenator did not oxygenate adequately and instead of improving, pao2 tended to decrease with the time.The event occurred intra-operative.The patient was not injured during the event and medical or surgical intervention was not required.No health hazards were reported at the time the information was obtained.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.The involved product code was identified as cx*fx05rea based on the actual sample.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.The test result shown below met the factory's control standards.No anomaly was found.Bovine blood conditions hb: 12 g/dl, temp.: 37°c., ph: 7.4, svo2: 65%, pvco2: 45mmhg circulation conditions blood flow rate: 2 l/min and 1 l/min, v/q:1, fio2: 100% o2 transfer volume at 2 l/min: 117 ml/min., at 1 l/min: 67 ml/min co2 removal volume at 2 l/min: 88 ml/min., at 1 l/min: 52 ml/min based on the investigation result, the gas transfer performance of the rinsed actual sample met the factory's control standards, and no anomaly was found in the manufacturing records.The cause of occurrence in this case could not be clarified due to lack of detailed information.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.

• Brand Name: CAPIOX FX05 OXYGENATOR
• Type of Device: 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: 16959974
• MDR Text Key: 315574776
• Report Number: 9681834-2023-00098
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK(FX05)
• Device Lot Number: 220512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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 Age: 2 YR
• Patient Sex: Male
• Patient Weight: 13 KG