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

Catalog Number CX-HC11L

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

Udi no.- not required for this product code.The actual device has been returned to the manufacturing facility and the evaluation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.(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 residual blood in the capiox device.Follow up communication with the user facility confirmed the following information: the volume of blood remaining in the actual device after the blood collection seemed larger than normal; and the patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the returned sample evaluation.Visual inspection found no anomalies in the appearance.After the actual sample was rinsed and dried another visual inspection found no anomalies which could be a trigger of clogging in the appearance.The sliced faces were subjected to visual inspection.No anomalies were found.The actual device was circulated with bovine blood, while ultrafiltrating performance and the pressure drop determined.They were confirmed to meet manufacturing specifications.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be definitively determined based on the available information, it is likely that the dehydrating performance of the actual sample was deteriorated due to the fibers being clogged.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 hemoconentrator 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." 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
• 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: 5744368
• MDR Text Key: 48007195
• Report Number: 9681834-2016-00149
• 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: 06/23/2016

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: 02/28/2019
• Device Catalogue Number: CX-HC11L
• Device Lot Number: 160307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• 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
• Treatment: SENKO TUBING PACK & RESERVOIR