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

Catalog Number CX-BPU27001

Device Problem Complete Blockage (1094)

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

Event Date 03/17/2016

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 fixed with glutarldehyde solution and the housings were removed for further inspection.It was found that clots had formed on the blood inlet and outlet sides of the device.A larger amount of clots were noted on the blood outlet side.The fiber was sliced in the longitudinal direction and its inside was inspected under electron microscope.It was found to have been clogged with the erythrocyte component.A comparative pressure drop test was conducted.The actual sample and a factory retained sample of 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 a clog in the actual sample.A factory retained sample 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 report of this nature with the involved product/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." "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: two hours after the extracorporeal circulation started, during suspension of the circulation, the customer noticed that the dehydrating performance of the actual sample became deteriorated; blood would not flow into the actual sample; the actual sample was being perfused by only the pressure generated by the centrifugal pump; the act at that moment was higher than 1000 seconds; the amount of blood loss was unknown; 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: 5572973
• MDR Text Key: 42497251
• Report Number: 9681834-2016-00079
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/13/2016

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-BPU27001
• Device Lot Number: 151215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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
• Patient Age: 70 YR
• Patient Weight: 56