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

Catalog Number CX-XRX43002A

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

Weight - (b)(6) kilograms.Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual device was discarded by the involved user facility and was not returned for evaluation, however, a photograph was provided for evaluation.A review of the photos noted the presence of thrombus adhering to the filter with the surface of blood inside the reservoir being lowered.The reported phenomenon of the thrombus melting like ice was not confirmed in the photos.The complaint file was searched back to the past two years for reports of the phenomenon of thrombus melting like ice.There has been no other report of this nature to date.A review of the device history record of the involved product code/lot number combination revealed no findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation, it is likely that the blood in which some coagulation factors had been activated flowed into the reservoir of the actual sample, resulting in the reported thrombus formation.The cause of the reported phenomenon of the thrombus melting like ice cannot be identified.However, the exact cause of the reported event cannot be definitively determined.The ifu states: "adequate heparinization of the blood is required to prevent it from clotting in the system." (b)(4).

Event Description

The user facility reported that red thrombus formed on the filter inside the reservoir of the capiox device immediately before the termination of the circulation.After the procedure, during blood collection, the red thrombus adhering on the filter melted like ice and disappeared.The product was not changed out.There was no blood loss.There was no harm to the patient.

• Brand Name: CAPIOX FX 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: 7974624
• MDR Text Key: 124002753
• Report Number: 9681834-2018-00191
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CX-XRX43002A
• Device Lot Number: 180420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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 Age: 74 YR
• Patient Weight: 63