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

Catalog Number CX-XRX31301

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual device was received for evaluation.Visual inspection revealed no obvious anomaly, such as a break, which could have led to the poor gas transfer performance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the manufacturer shipping inspection protocol.Bovine blood condition: hb12.0 g/dl temp.37°c., ph: 7.4, svo2: 65% and pvco2: 45mmhg; circulation condition: flow rate of 6l/min and 4l/min, v/q=1, fio2=100%; test results: o2 transfer: @6l/min.= 391ml/min.@4l/min.= 280ml/min; co2 removal: @6l/min.= 315ml/min.@4l/min.= 236ml/min.No anomalies were revealed in the gas transfer performance, with the obtained values meeting the manufacturer specifications.Review of the pump record revealed that the fio2 at the start of ecc was 65%; cooling started at 15:05 and rewarming started at 16:34.After the rewarming started, whereas the cystic temperature increased, svo2 decreased.When the rewarming started, fio2 was 66%; from 16:53 to 17:19, po2 decreased along with decreasing svo2.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase 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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that circulation conditions during usage (flow rate, fio2, etc.) became insufficient for the patient's o2 consumption; the volume of supplied o2 became insufficient for the o2 consumption volume that increased due to the patient's metabolism activated by the rewarming, resulting in decrease in svo2 and po2.However, the exact cause of the reported event cannot be definitively determined based on the available information.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 Description

The user facility reported that the involved capiox custom pack was used during the procedure.The po2 was low from the beginning of cpb.According to the pump record, po2 started to decrease at 17:20.Increasing fio2 could not improve it.They increased fio2.The procedure was completed successfully.The patient was not harmed.The composition of the priming solution was unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: 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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 9797377
• MDR Text Key: 192205165
• Report Number: 9681834-2020-00030
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2020

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 Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CX-XRX31301
• Device Lot Number: 191010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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