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

Catalog Number CX-XRZ23001

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6) hospital 510(k): k130280.The device was returned for evaluation.Visual inspection upon receipt found a substance white in color adhering to the inside wall on the graduation side.There was not any obvious anomaly, such as a break, in the appearance.The actual device was disassembled and the foreign substance white in color was collected.Sem-edx (scanning electron microscope - energy dispersive x-ray spectrometry) elementary analysis of the foreign substance detected some elements constituting organic substances, including nitrogen and sulfur.Ft-ir (fourier transform infrared spectroscopy) qualitative analysis of the foreign substance obtained the spectrum of protein.The cardiotomy filter and the defoamer taken out of the cardiotomy filter, after having been rinsed in physiological saline solution, were subjected to visual inspection.The presence of clots was noted on the defoamer.Based on the investigation, the foreign substance white in color adhering to the inside wall of the actual sample was found to be protein derived from a living body.Some clots were found to have formed on the defoamer of the cardiotomy filter.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely when blood in which coagulation factors has been activated flows into the reservoir and stayed on the solution level, clots may start to form there.However, 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 during the circulation, the customer found a foreign substance white in color, which he thought was a white thrombus, adhering to the inside wall of the reservoir on the area around the graduation of 600ml.The customer completed the procedure successfully without changing out the actual sample and there was no blood loss or 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
• MDR Report Key: 8435518
• MDR Text Key: 139454157
• Report Number: 9681834-2019-00026
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: CX-XRZ23001
• Device Lot Number: 181023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• 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