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

Catalog Number CX-XRY53702

Device Problem Increase in Pressure (1491)

Patient Problem Blood Loss (2597)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted explanted date: device was not explanted pma/510k: 510k - k130520.The actual sample was received for evaluation.Visual inspection revealed no obvious anomalies, such as a break, in the appearance.Physiological saline solution was flowed into the actual sample, blood channel was inspected visually.No formation of blood clots was observed.The actual sample before rinsed was built into a circuit with tube, and then physiological saline solution was circulated in the blood channel, while the pressure drop was determined at each flow rate.The obtained values were confirmed to be equivalent to that obtained from a current product sample.The actual sample was rinsed, dried, and bovine blood (hb12g/dl and temp.37oc) was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the manufacturer specifications.No obstruction was confirmed.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no findings.Ifu states: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.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 the normal product.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 capiox custom pack was used during the procedure.Blood in surgical field was sucked; it seemed that recirculation was performed to concentrate blood.(act was about 400 at the beginning).Due to the preparation on the operative field side, it took long time until the pump was on.After the pump started, the flow rate increased up to the half of the target level; however, would not increase further.Increasing pressure (over 300 mmhg) was also observed in the oxygenator.Since it was just after the pump started, they interrupted and replaced it with fx25e.Blood loss was 300 ml.The procedure was completed successfully.The patient impact was not reported.

• Brand Name: CAPIOX FX 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; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 10104570
• MDR Text Key: 193012555
• Report Number: 9681834-2020-00077
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CX-XRY53702
• Device Lot Number: 191213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• 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
• Patient Outcome(s): Other