MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*RX25RE
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.Visual inspection revealed that no damage or other anomalies leading to pressure drop.The actual sample was rinsed, the blood channel was filled with normal saline (colored for better visibility), the blood outlet port was occluded, and then air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port.As a result, no leak occurred.The actual sample was built into a circuit with tubing, and then the pressure loss was measured while bovine blood (hct 35%, temp.37°c) was circulated at each flow rate.The results were within the manufacturers specifications, and no anomaly was found that would lead to a pressure drop.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.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.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that pre-treatment; while the user was priming the capiox device, the pressure of the oxygenator or circuit decreased.They found that the oxygenator's arterial tubing value downing during the priming procedure.The procedure was completed successfully.The patient was not harmed.

• Brand Name: CAPIOX RX25 OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 12279498
• Report Number: 9681834-2021-00128
• Device Sequence Number: 17060887
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 210120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1