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

Catalog Number CX*RX25RW

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Information (3190)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was returned for evaluation, and the photos and movie showing the complaint issue were provided for evaluation.The photos and movie were reviewed; air bubbles were flowing out of the upper part of the venous filter, the blood level inside the venous filter has exceeded that inside the hard-shell reservoir, there are air bubbles on the surface of the blood pooled inside the hard-shell reservoir, and the cap to be attached to the auxiliary port is missing.The actual sample was inspected, and visual inspection revealed no obvious anomaly, such as a break, in the appearance.Some of the caps were not in place on the lid of the reservoir and were not returned along with the actual sample.The actual sample was rinsed, built into a circuit with tubes and tested with the use of bovine blood for the defoaming performance of the venous filter.There was no air bubble appearing on the surface of blood (to perform this test, the factory-retained caps were applied to the ports as needed).With the blood level in the hard-shell reservoir kept at 2500ml (the same level as that shown in the provided photo) the same test as the one in above was conducted.No air bubble was noted on the surface of blood.Bovine blood was circulated in the circuit in the manner where air was being suctioned into the venous line.This resulted in flow-out of air bubbles from the upper part of the venous filter.Air mingled into the venous filter is defoamed by the defoamer set inside the venous filter.In this complaint, however, the defoamer was not able to catch up with removal of air bubbles coming into the reservoir continuously, resulting in flow-out of air bubbles from the upper part of the venous filter.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.Ifu states: make sure the caps of unused luer ports are tightened firmly to prevent the leakage.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that air bubbles suctioned into the venous line were accumulated in the venous filter and finally flowed out of the upper part of the venous filter.However, the exact cause of the reported event cannot be definitively determined based on the state of the actual sample and the available information.(b)(4).

Event Description

The user facility reported that after cpb started, the perfusionist found that air bubbles continue to appear from the blood in the capiox reservoir.The procedure outcome and patient impact was reported to be unknown.Additional information was received on june 13, 2019.The actual sample was changed out.

• Brand Name: CAPIOX RX OXYGENATOR
• 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8708854
• MDR Text Key: 148328249
• Report Number: 9681834-2019-00099
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 181210C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 60