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

Catalog Number CX-XRZ23001

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Udi not required for product code.Implanted date: device was not implanted; explanted date: device was not explanted; occupation-clinical engineer; pma/510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed no break, or no other obvious anomaly that could lead to the reported drop in oxygenation performance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, no anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications.[blood conditions] hb:12g/dl, temp.: 37°c., ph:7.4, svo2:65%, pvco2: 45mmhg.[circulation conditions] blood flow rate: 2l/min and 1l/min, v/q=1, fio2=100%.[o2 transfer volume] @2l/min= 121 ml/min.@1l/min= 68 ml/min.[co2 removal volume] @2l/min= 98 ml/min.@1l/min= 56 ml/min.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Review of the pump record involved in this complaint revealed: circulation started with blood flow rate: 0.6 l/min, gas flow rate: 0.4 l/min, and fio2:50%.Pressure drop showed no increasing tendency and was confirmed to have changed in accordance with the change in the blood flow rate.Based on this, it is likely that the reported event did not come from a formation of blood clot that prevents the contact between blood and gas.Rewarming was started one and a half hours after the pump was on, which was coincided with the timing when the oxygenation drop was noted.Svo2 was 74% at 13:11 when the rewarming was started, at that time the blood flow rate was 0.9 l/min, gas flow rate was 0.4 l/min, and fio2 was 50%.Afterward, svo2 shifted at around 70%.At the time of rewarming, pao2 was found not increased though fio2 was increased to 60% at 13:12 and to 65% at 13:30.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 pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing in patients metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed to the amount of the patient's gaseous metabolism.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.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 normal product.It is likely that the volume of supplied o2 was insufficient because fio2 was not 100%; gas flow rate was insufficient for the blood flow rate because v/q ratio was not 1; required o2 volume increased because the patient's metabolism was activated during rewarming; due to the wet lung phenomenon, water droplets were generated in the gas channel, which hindered the contact between blood and gas, making it difficult to exchange gas.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 the involved capiox custom pack was used during the procedure.The oxygenation performance dropped one and a half hours after the pump was on.They coped by increasing fio2.There was no harm to the patient.The procedure outcome was not reported.

• Brand Name: CAPIOX CUSTOM PACK
• 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 08873 ; 8002837866
• MDR Report Key: 10866920
• MDR Text Key: 217707340
• Report Number: 9681834-2020-00233
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CX-XRZ23001
• Device Lot Number: 200806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• 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