MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15 HOLLOW FIBER OXYGENATOR AF

Catalog Number CX-XRY07702

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device and a photo were returned to the manufacturing facility for evaluation.A review of the photo during the actual use provided by the customer confirmed the reported complaint.The presence of white clot-like substance can be seen adhering around the fluid level graduation of 100 - 300ml.Visual inspection of the actual device found it had been marked with a large black circle and a small black-circle.In the small circle, the adhesion of white clot-like substance was found.In the large one, no such a substance was visible.There was no adhesion of white clot-like substance on the remainder of the reservoir.The white clot-like substance was fixed with glutaraldehyde solution and a specimen was sampled.Magnifying inspection of the specimen found it had a layered structure.The white clot-like substance was subjected to a ft-ir qualitative analysis and identified as protein.The white clot-like substance was subjected to a sem/edx elementary analysis and found to consist of c (carbon), o (oxygen), n (nitrogen), p (phosphorus) s (sulfur) and na (sodium).Electron microscopic inspection of the white clot-like substance found degeneration had progressed.This prevented the traces of blood corpuscles and fibrin nets from being observed.A review of the device history record of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file found no report of this nature with the involved product/lot# combination.Based on the evaluation result, the white clot-like substance is likely to be protein-origin, consisting of carbon, oxygen, nitrogen, phosphorus, sulfur and sodium.From the results of the sem/edx elementary analysis and the electron microscopic inspection, the scenario or cause of the formation of the substance cannot be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported thrombus in the capiox fx15 device.Follow up communication with the user facility confirmed the following information: the actual sample was primed with donated blood and re-circulated with it for two hours with no involvement of the patient.It was reported the customer found the adhesion of white clot-like substance on the graduated front wall of the reservoir.The composition of the prime and the order of the administration of each drug are as follows: (1) solyugen 1200ml (2) salinhes fluid solution (hydroxyethylated starch) 500m (3) mannigen 150ml (4) heparin 4,3ml (5) saline solution 1000ml (6) rcc 280ml x 2 packs (7) solyugen (8) transamine 20ml (9) cacl2 2ml; (10) the device was changed out; (11) the procedure was completed successfully; and (12) it was reported no harm to the patient.

• Brand Name: CAPIOX FX15 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENATOR
• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5401421
• MDR Text Key: 37243881
• Report Number: 9681834-2016-00005
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CX-XRY07702
• Device Lot Number: 151014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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