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

Catalog Number CX-FX15RW40V

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: not required for product code; implanted date: device was not implanted; explanted date: device was not explanted; 510(k) - k130520.The actual sample was received for evaluation.Visual inspection revealed no obvious anomaly, such as a break, in the appearance.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 arranged to hb 12.0g/dl, temp.37deg c., ph:7.4, svo2: 65% and pvco2:45mmhg was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2 =100% and the flow rate of 5l/min.And 3l/min.Result: o2 transfer: @5l/min.= 307ml/min.@3l/min.= 206ml/min, co2 removal: @5l/min.= 264ml/min.@3l/min.= 178ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the manufacturer specifications.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.Review of the pump record involved in this complaint revealed that during the first 40 minutes, paco2 was high, but tended to decrease gradually.Pvco2 data was not included in the record; regarding pao2, no decreasing trend was observed though circulation was done with fio2 around 50%.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.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.It is likely that since co2 gas was blown during the priming, pco2 contained in the priming solution had increased, and pvco2 immediately after the start of circulation was high, the paco2 was high accordingly; or gas flow rate was insufficient due to low v/q.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that after setting the capiox oxygenator and tubing, co2 was flushed to expel air before the priming process.After that, 3l of o2 was blown to expel co2.Hi in co2 was shown during cdi calibration.Despite re-flushing with 3.5l, it was not improved.Though the situation was not improved, the pump was started at 12:10 with fio2 60% x 2l.Pco2 was 71.4 at 12:19.No issue was found in the oxygenation performance.At 12:20, fio2 was changed to 45% x 5l.As a result, pco2 become 50-60mmhg, which was higher than the hospital standard of 40-50mmhg.Normally, gas flow rate is controlled to become half of the blood flow rate; however, in this case, they were necessary to be kept around 1:1 - 1: 1.2.Without increasing o2, co2 could not be expelled.Gas was apparently difficult to be expelled.Issue was coped by increasing gas flow rate.The oxygenator was not exchanged.The patient was not harmed.The procedure outcome was not reported.

• 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 9552419
• MDR Text Key: 216656614
• Report Number: 9681834-2019-00234
• 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: 01/06/2020

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: 04/30/2022
• Device Catalogue Number: CX-FX15RW40V
• Device Lot Number: 190516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2019
• 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