MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number CX*HC11L

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the capiox hemconcentrator was stuck and there was no function during bypass after two hours.They changed out the device to a new one to allow the procedure to keep going until the end.The procedure outcome and patient impact was reported to be unknown.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection of the actual sample upon receipt revealed no obvious anomaly, such as a break, in the appearance.The actual sample was rinsed, subjected to another closer visual inspection and confirmed not to have any anomaly, such as a break, which could have led to the clogging of the fiber.The actual sample was built into a circuit with tubes.With a help of a roller pump, bovine blood (ht25% , 37°c) was let to flow through the circuit.As a result, normal flow rate was obtained.The actual sample was tested for its ultrafiltration performance.The obtained result was confirmed to meet the manufacturer specifications.The pressure loss was determined during the circulation at the flow rate of 500ml/min and tmp of 400mmhg.The obtained result was confirmed to meet the manufacturer specifications.Ifu states: adequate heparinization of the blood is required in order to prevent it from clotting in the system.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 100 ml/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 of least 50 ml/min is recommended even if ultrafiltration is stopped by clamping the filtrate line.Bubbles in the system may cause clotting and blood damage.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that due to some factor(s), the rate of the flow going into the actual sample was decreased, causing blood to get concentrated excessively and plug the fibers; blood which had become high in concentration due to the administration of packed red blood cells or due to removal of water contained in blood entered the actual sample, got further concentrated and plugged the fibers.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9606485
• MDR Text Key: 220565804
• Report Number: 9681834-2019-00240
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04987350738417
• UDI-Public: 04987350738417
• Combination Product (y/n): N
• PMA/PMN Number: K973516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CX*HC11L
• Device Lot Number: 190510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1