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

Catalog Number CX-XR270M02

Device Problem Complete Blockage (1094)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed no anomalies in the appearance.The comparative pressure drop test was conducted as follows.The actual sample and a factory-retained sample with the involved lot number were circulated with saline solution while the pressure drop was determined.The actual sample was found to have a higher pressure drop, indicating that the actual sample became clogged.Visual inspection found that clots had formed both on the blood inlet side and on the blood outlet side.The actual device, after having been rinsed and dried, was circulated with bovine blood, while ultrafiltrating performance and the pressure drop were determined.They were confirmed to meet manufacturing specifications.A review of the device history record 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.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." "do not exceed 50% hematocrit at the blood outlet during ultrafiltration." 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: clotting in the actual device was noted one hour after initiation of the extracorporeal circulation; the actual device was replaced with a new hemoconcentrator; the procedure was completed successfully; blood loss was less than 100 ml; and there was no harm to the patient.

• 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: 5650040
• MDR Text Key: 45031578
• Report Number: 9681834-2016-00117
• 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
• Report Date: 05/12/2016

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: 05/31/2017
• Device Catalogue Number: CX-XR270M02
• Device Lot Number: 151210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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
• Patient Age: 60 YR