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

Catalog Number CX*HC11L

Device Problem Filtration Problem (2941)

Patient Problem No Information (3190)

Event Date 04/08/2019

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 the shipping inspection record from the reported product code/lot number combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that after 4.5 hrs the involved capiox hemoconcentrator was stuck, the procedure was reported to be the same as usual.They changed to a new one to continue the bypass surgery.The patient impact and procedure outcome was reported to be unknown.

Manufacturer Narrative

This report is being submitted as follow up no.1 update section h3, and to provide the completed investigation results.The actual device was received for evaluation.Visual inspection revealed no obvious anomalies such as a break, in the appearance.The actual sample was rinsed and was built into a circuit with tubes.With a help of a roller pump, bovine blood at ht25% and 37oc was let to flow through the circuit.The bovine blood flowed through the actual sample.However, the blood started to leak out to the blood outlet side and pooled in the filtrate phase.A fiber leak was found.This prevented the ultrafiltration performance from being determined.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.Based on the complaint description, the actual sample was able to be used for 4.5 hours before the occurrence of clogging.It is likely that the actual sample was subjected to some shock force after the use, during transportation back to ashitaka factory and the fiber became cut.From the state of the actual sample, 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, shizuoka 418 ; JA 418
• MDR Report Key: 8556567
• MDR Text Key: 147622953
• Report Number: 9681834-2019-00066
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: CX*HC11L
• Device Lot Number: 180910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1