MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR; DIALYSATE SYSTEM

Catalog Number	CX*HC11L
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason code 20 was used in the conclusions section of h6.A review of the device history record and shipping inspection record of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported an issue with the capiox hemoconcentrator device during a procedure.Follow up communication with the user facility confirmed the following information: it was reported the filter function did not work; and the perfusionist immediately changed the defect sample to a new one.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the actual device evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies in the appearance.The actual device was rinsed dried and subjected to another visual inspection.There were no anomalies in the appearance.The actual device was circulated with bovine blood while ultra-filtrating performance and the pressure drop were determined.They results were confirmed to meet manufacturing specifications.There is no evidence that this event was related to a device defect or malfunction.The actual sample after having been rinsed and dried was verified to have normal performance in the pressure drop and the ultra-filtrating.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the dehydrating performance of the actual device was deteriorated due to the fibers being clogged.As a cause of the fibers being clogged, the below factors can be inferred experientially.Due to some factor(s), the flow rate of blood going into the actual device was decreased.By this, blood was concentrated excessively and clogged in the fibers.Blood concentrated due to administration of packed red blood cell or inflow of dehydrated blood was further concentrated when it flowed into the actual device and became clogged in the fibers.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: the capiox hemoconcentrator is designed to operate at flow rates within the range of 100 to 500 ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100ml/min blood flow may cause blood coagulation in the device.Stop using the hemoconcentrator if blood leakage, clotting or any other problem is observed.Replace it with a new one.Do not exceed 50% hematocrit at the blood outlet during ultrafiltration.Do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow of at least 50ml/min is recommended even if ultrafiltration is stopped by clamping the filtrate line.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Common Device Name: DIALYSATE SYSTEM
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; TW 418
• MDR Report Key: 6735712
• Report Number: 9681834-2017-00147
• Device Sequence Number: 13886512
• Product Code: KDI
• UDI-Device Identifier: 04987350738417
• UDI-Public: (01)04987350738417(17)200131(10)170213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K973516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: CX*HC11L
• Device Lot Number: 170213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1