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

Catalog Number CX-XP21702

Device Problem Complete Blockage (1094)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no obvious anomalies in the appearance.The actual sample was rinsed, dried and subjected to another visual inspection.No anomalies were revealed.Bovine blood was circulated in the blood pathway.No anomalies or clogging was observed.A review of the device history record and the product release decision control sheet 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.The exact cause of the reported event cannot be determined and there is no evidence that this event was related to a device 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 500ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100 ml/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." and "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." (b)(4).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 a clog in the capiox device.Follow up communication with the user facility confirmed the following information: the hemoconcentrator was clogged; the procedure was completed successfully; and the patient was not harmed.

Manufacturer Narrative

As stated, this report is being submitted as follow-up no.1 for mfg.Report no.9681834-2016-00035 to make a correction to the 510(k) number initially documented.The initial number documented was k022115, the correct lot number is k973516.

Event Description

This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2016-00035 to make a correction to the 510(k) number initially documented.The initial number documented was k022115, the correct lot number is k973516.

• 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: 5476003
• MDR Text Key: 39865972
• Report Number: 9681834-2016-00035
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/03/2016

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: 02/28/2017
• Device Catalogue Number: CX-XP21702
• Device Lot Number: 150915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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