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

Catalog Number CX-XR270M024

Device Problem Complete Blockage (1094)

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

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies in the appearance.There was no formation of clots inside the device.The actual sample, after having been rinsed, was subjected to another visual inspection.No break or plugging in the fiber was confirmed.The actual sample was built into a circuit with tubes, where bovine blood flowed directly.Blood was confirmed to run through the device.There was no difficulty with the filtrate pathway being filled with filtrate.Bovine blood was circulated in the circuit at the flow rate of 500ml/minute and tmp 400mmhg.During the circulation, the pressure loss was determined.The obtained values were confirmed to meet manufacturing specifications.Subsequently, the ultrafiltration performance was determined and verified to meet manufacturing specifications.A review of the device history record and 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.There is no evidence that this event was related to a device defect or malfunction.The inspection results verified the actual device was the normal product.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the volume of the blood sent into the actual sample was not sufficient.The device labeling does address the potential for such an event in the instruction for use (ifu) with statements 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.Do not exceed 50% hematocrit at the blood outlet during ultrafiltration.Do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow at least 50l/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 during a procedure.Follow up communication with the user facility confirmed the following information; hemoconcentration started immediately after the initiation of the circulation with the pressure applied only with the centrifugal pump; five minutes later, removed water did not come out of the filtrate side with the blood flow being normal; the pressure inside the circuit was increased from 300mmhg to 400mmhg; and once pressure was increased water started flowing sufficiently.

• 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: 6471547
• MDR Text Key: 72347023
• Report Number: 9681834-2017-00063
• 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: 04/07/2017

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: 12/31/2017
• Device Catalogue Number: CX-XR270M024
• Device Lot Number: 160729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 50