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

Catalog Number CX-XRX16603

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/13/2022

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.Inspection of the actual sample was performed.Visual inspection upon receipt did not find a breakage or other anomaly that could lead to a poor oxygenation in the appearance.Gas was blown from the gas inlet side of the actual sample.As a result, no liquid flowed out of the gas outlet side.Therefore, it was considered that no plasma leak had occurred.The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually.Formation of blood clots was observed on the bottom.Since most of the clots were found on the bottom, it was thought to be blood settled on the bottom and coagulated during return.The actual sample after cleaned and dried was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, the obtained values met the factory specifications, and no anomalies were revealed.[bovine blood conditions] hb:12g/dl, temp.: 37°c., ph:7.4, svo2:65%, pvco2: 45mmhg [circulation conditions] blood flow rate: 6l/min and 4l/min, v/q=1, fio2=100% [o2 transfer volume] at 6l/min= 383 ml/min.At 4l/min= 274 ml/min [co2 removal volume] @6l/min= 319 ml/min.@4l/min= 233 ml/min.Record review was performed.The provided patient's arterial blood sample data showed as follows.From 11:19 to 12:14, paco2 increased (33.8 mmhg at 11:19 and 63.4 mmhg at 12:14).From 12:15 to 12:30, gas flow rate was increased to 10l/min.After that, it was decreased gradually until 14:44.No record after 14:44 was provided.From 12:14 to 12:51, paco2 decreased, and then no changes in paco2 such as seen from 11:19 to 12:14 were observed.Pao2 between 11:19 and 12:14 was unchanged.Review of the manufacturing record and the product-release judgement record of the involved product/lot# combination confirmed there was no anomaly in them.A search of the complaint file found no similar report with the involved product code/lot# combination.Ifu states: "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.(page9, d.During perfusion) upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increasing in patient's 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.(page7, precaution) 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 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.(page10 warning)" based on the investigation result, it is conceivable as a possible factor of increasing paco2, from the fact that changes in abg were observed only with paco2 and paco2 increased gradually after the start of circulation, based on our experience, removal of co2 gas became difficult because reducing the blood temperature was started at the same time the circulation was started.However, from the state of the actual sample and the pump record, the cause of occurrence could not be clarified.(b)(4).

Event Description

The user facility reported that the capiox custom pack co2 removal was poor from the time the pump was turned on, so the circulation was continued with gas flow rate at 10l/min.They considered there was no problem with the actual use and continued using it.The surgery was completed successfully.The patient was not harmed.

• 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: stephanie handy ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 13506202
• MDR Text Key: 286871825
• Report Number: 9681834-2022-00003
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CX-XRX16603
• Device Lot Number: 200915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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