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

Catalog Number	CX*HC11L
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional 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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9681834-2019-00066
• Device Sequence Number: 2256841
• Product Code: KDI
• UDI-Device Identifier: 04987350738417
• UDI-Public: 04987350738417
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K973516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1