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

Catalog Number	CX*HC11S
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was discarded by the facility.Therefore the investigation was limited to the user facility information, quality records, and a retention sample from the involved product code/lot# combination.Visual inspection of the retention sample found no anomalies in the appearance.The device was circulated with bovine blood at the flow rate of 500ml/min by using a roller pump.Blood was confirmed to run through it with no difficulty.Bovine blood was circulated through the device while ultra-filtrating performance and the pressure drop was determined.The obtained value was confirmed to meet manufacturing specification.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.The investigation results verified that the retention sample was normal product.Based on the available information, the cause for the reported event cannot be definitively determined.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure.However, there is no indication that the reported event was related to a product defect or malfunction.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement 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." 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.H3 other text : sample discarded.
Event or Problem Description
The user facility reported clogging during the use of a capiox device.Follow up communication with the user facility confirmed the following information: the perfusionist connected the hemoconcentrator to the cpb; blood was going through the inlet but not coming out of the outlet; the filtrate was red in color and lesser in amount; the procedure was completed successfully; and the patient was not harmed.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Common Device Name: DIALYZER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5960675
• Report Number: 9681834-2016-00225
• Device Sequence Number: 16241061
• Product Code: KDI
• UDI-Device Identifier: 04987350738394
• UDI-Public: 04987350738394
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 09/19/2016

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: 03/31/2017
• Device Catalogue Number: CX*HC11S
• Device Lot Number: 140418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2016
• Initial Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1