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

Catalog Number CX-RX25RW

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

Udi not required for product code; implanted date: device was not implanted; explanted date: device was not explanted. The actual device was received for evaluation. Visual inspection revealed no obvious anomalies, such as a break, in the appearance. Physiological saline solution was let to flow into the blood channel by gravity drop. Visual inspection of the oxygenation module did not find any blood clot on that area. The actual sample before being rinsed was built into a circuit with tubes. Physiological saline solution was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to be slightly higher than those obtained from a current product sample. The actual sample, after having been rinsed and dried, was built into a circuit with tubes. Bovine blood (hb12g/dl and temp. 37 deg. C) was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to meet the factory's specifications. No obstruction was observed. Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings. Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. 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. White substances were observed on the competitor's arterial filter, and the issue was found just before the end of the procedure, it is likely that the circuit was obstructed due to some factors and, as a result, the increase in the pressure drop occurred. 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 open heart surgery when the roller pump was operated, the pressure of the oxygenator increased. The pressure of the arterial filter in a competitor's circuit also increased. They finished the procedure without exchanging the oxygenator since the issue occurred just before the end. In addition, it was reported that white substances were observed on the arterial filter. There was no harm to the patient. The procedure outcome was not reported.

• 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: 9254782
• MDR Text Key: 219164464
• Report Number: 9681834-2019-00185
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040210
• 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: 10/30/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CX-RX25RW
• Device Lot Number: 181206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial