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

Catalog Number ZZ*FX25RW

Device Problem Air/Gas in Device (4062)

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

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

Udi not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation-chief perfusionist.Pma/510(k)- k130520.The actual device was not returned, therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not obstruct gas outlet port.Avoid build-up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.The gas flow rate should not exceed 20l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 1 l/min.Minimum operating volume in the reservoir is 200 ml.Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient.Ensure that the de-airing process is complete prior to initiating bypass.With no return of the actual device, 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 device was used during the procedure.The chief perfusionist stated foam development for no apparent reason after approximately 45 minutes bypass time.Negative and positive pressure tests were performed, there was no leakage.The reservoir did not need to be replace.The type of intervention was a reconstruction of the pulmonary bifurcation.The blood loss was nominal, reconditioning cell saver.There was no significant delay in the surgery.The procedure was completed successfully.The patient was not harmed.

• Brand Name: CAPIOX FX25
• 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: 10596171
• MDR Text Key: 208862348
• Report Number: 9681834-2020-00191
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: ZZ*FX25RW
• Device Lot Number: 190712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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
• Treatment: HEPARIN; TRANEXAMIC ACID
• Patient Age: 21 YR
• Patient Weight: 78