MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number ZZ*FX25RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Age & date of birth - year provided: (b)(6).Lot number- potential lot- 190305; expiration date: 28feb202022; manufacturer date: 05mar2019.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the involved capiox device was used and there was inadequate oxygenation and co2 elimination right at the start of the bypass.Despite fio2 100% and gas flow 15 liters/minute, max.Po2 from 74.7 mmhg and pco2 increased to 72.2 mmhg.An increase in pressure gradient was not observed.The oxygenator was replaced while the patient was in a hypothermic status after approximately 35 minutes bypass time (duration: 3.5 minutes).The type of intervention was an exchange homograft in the pulmonary position.The blood loss was approximately 400ml during the replacement of the oxygenator.There was no information available regarding medication.The surgery had been delayed approximately 15 min.Patient treatment was performed as intended due to the replacement of the oxygenator.Due to low oxygenation, there was potential patient harm.The procedure outcome was successful.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.A correction to the lot number is being provided, it was initially reported the device lot number was 181228; however, it was confirmed to be 190531.Therefore, sections d4: lot # and expiration date, and h4 have been updated.The actual sample 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 factory's shipping inspection protocol.Bovine blood condition: hb: 12.0g/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 result: o2 transfer: @6l/min: 370ml/min.@4l/min: 265ml/min.Co2 removal: @6l/min: 335ml/min.@4l/min: 243ml/min.The test result met manufacturer specifications and no anomaly was noted in the gas transfer performance.Reproductive testing was performed, and the venous blood prepared to svo2 25% and 65% each were circulated through the actual sample under the following circulation conditions.Condition 1: blood flow rate: 4.5l/min, gas flow rate: 2.0l/min, fio2: 60%.Condition 2: blood flow rate: 4.5l/min, gas flow rate: 2.0l/min, fio2: 100%.Condition 3: blood flow rate: 4.5l/min, gas flow rate: 5.0l/min, fio2: 100%.Pao2 value under each condition were confirmed as follows.Svo2=25%: condition 1: 42.8mmhg; condition 2: 71.5mmhg; condition 3: 71.7mmhg.Svo2=65%: condition 1: 87.1mmhg; condition 2: 346mmhg; condition 3: 368mmhg.A review of the device history record of the product code/lot# combination and product release decision control sheet was conducted with no findings.Review of the pump record revealed from 11:15 (start of circulation) to 11:18, the blood flow rate was 4.54l/min, gas flow rate was 2l/min, and fio2 was 60%.Ci was controlled to be 2.4 while the actual sample was in use.Po2 and pco2 were not mentioned in the record.Fio2 was raised to 70% at 11:18, to 80% at 11:19, and to 100% at 11:21.The ppr stated that gas flow was set at 15l/min.The pomp record showed that it was in the range of 2 - 5l/min while the actual sample was in use.Pressured drop stayed around 70mmhg.From this, no obstruction may have occurred.The actual oxygenator was exchanged at 11:55.Ifu states: 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.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.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9762549
• MDR Text Key: 195039554
• Report Number: 9681834-2020-00020
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: ZZ*FX25RW
• Device Lot Number: 190531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 70