MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZERS

Model Number DD+ELISIO-21H

Device Problems Improper or Incorrect Procedure or Method (2017); Output Problem (3005); Priming Problem (4040)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Clinic stated that they have experienced an increase in clotted dialyzers since switching from optiflux dialyzers to elisio dialyzers.Treatments are interrupted, and most are unable to return the patient's blood.The clotting is not patient, dialyzer size, or user specific.7 total incidents reported in (b)(6): (b)(6) 2021 - 1 incident, (b)(6) 2021 - 2 incidents, (b)(6) 2021 - 1 incident, (b)(6) 2021 - 1 incident, (b)(6) 2021 - 1 incident.Clinical specialist contacted the facility and offered in-person product training for may 3, 4, and 5th 2021.Clinic was advised to follow ifu for proper priming instructions, because the staff was following clinic protocols and not the product ifu.After our clinical specialist visited the clinic and observed the staff during priming and recirculating process, it was identified that the clinic was recirculating with 100ml instead of 200ml as instructed in the ifu.Arterial chambers were also observed not be be 75% full in some cases.During her visit to the clinic, the nurse manager advised that a patient required a blood transfusion 2 days after treatment was interrupted and the patient's blood could not be returned due to the clotted dialyzer.All data was documented and an email with her findings was sent to the nurse manager, providing instructions for proper priming, recirc, and levels of bloodline chambers.Initial date of occurence is unknown.Clinic stated the first incident occurred sometime in (b)(6).Dialyzer size for product in question received 04/28/2021.

• Brand Name: NIPRO ELISIO-H DIALYZERS
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 11898833
• MDR Text Key: 281416612
• Report Number: 1056186-2021-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790007139
• UDI-Public: 00383790007139
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 05/27/2021

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: 11/30/2023
• Device Model Number: DD+ELISIO-21H
• Device Catalogue Number: DD+ELISIO-25H
• Device Lot Number: 20L14E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2021
• Distributor Facility Aware Date: 04/01/2021
• Device Age: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other