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

Catalog Number CX-RX15RW30

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual device was returned for evaluation.Visual inspection upon receipt revealed no anomaly, such as a break, in the visual appearance.Saline solution was let to flow through the actual device by gravity.Another unaided visual inspection of the actual device revealed no visible clot formation.The actual device was built into a circuit with tubes.Saline solution was filled and circulated in it and the pressure drop was determined at each flow rate.As the result, the pressure drop was found to be slightly higher than that of the current product.The actual device was rinsed and dried.Bovine blood was circulated in it and the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the manufacturer specifications.A review of the device history record of the reported product code/lot number combination was conducted with no findings.The investigation result verifies that the actual device, after having been rinsed, was the normal product with no anomaly which can be a trigger of the rise in the pressure loss.As a cause of this complaint, it is likely that the recirculation of the blood of which coagulation factor had been activated by the administration of protamine led clots to be formed, resulting in the reported pressure rise.However, the exact cause of the reported event cannot be definitively determined.Ifu reference: "adequate heparinization of the blood is required to prevent it from clotting in the system." (b)(4).

Event Description

The user facility reported clots were found in the capiox device.After the completion of a five hour extracorporeal circulation, during the administration of protamine, bleeding started.The administration of protamine was suspended and another extracorporeal circulation was started.After about one hour of circulation, with a rise in the pressure inside the circuit, clots were noted inside the device.The actual sample was changed out to a spare fx15 and the extracorporeal circulation was successfully completed.The amount of blood loss was reported to be unknown.

• Brand Name: CAPIOX RX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8124192
• MDR Text Key: 129031819
• Report Number: 9681834-2018-00211
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051997
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CX-RX15RW30
• Device Lot Number: 180508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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