MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RW

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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 the capiox device oxygenator did not maintain the priming solution.It empties, so they checked connections and adjust, however positive pressure that empties oxygenator persists.There were not any cracks.Finally, the doctor changed medical device doing nothing else than usual procedure and that worked perfectly.The issue was found during priming, there was no delay.The product was changed out, surgery was completed without patient harm or blood loss.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide an update to section d9, update section h3, and to provide the completed investigation results.It was initially reported that the actual device was available; however, confirmation was received that the sample is not available for return.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Ifu states: 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 0.5l/min.Maintain a minimum operating level of 15ml in the reservoir at all time.When capiox fx05 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir.This prevents gaseous emboli from entering the blood phase from the gas phase.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12781100
• MDR Text Key: 282120998
• Report Number: 9681834-2021-00200
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 200910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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