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

Catalog Number CX*HC11S

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2016

Event Type  malfunction  

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." (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Sample discarded.

Event 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
• Type of Device: DIALYZER
• 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: 5960675
• MDR Text Key: 55078007
• Report Number: 9681834-2016-00225
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04987350738394
• UDI-Public: 04987350738394
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K973516
• 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: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: CX*HC11S
• Device Lot Number: 140418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2016
• Initial Date FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2014
• 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