MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO ELISIO- H HEMODIALYZER

Model Number ELISIO-25H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Headache (1880); Local Reaction (2035); Weakness (2145); Numbness (2415)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Investigation reports attached on retained samples and unused/unopened returned sample. (b)(4).

Event Description

After 20 minutes into dialysis treatment, using the nipro elisio eli 25 h dialyzer, the patient started to suffocate, feel weakness, headache, numbness of the mouth which required use of antihistamine. After stopping the dialysis, the patient was fine. Furthermore, patient was using previously other similar product from another manufacturer (b braun xevonta hi 23) without any complications.

• Brand Name: NIPRO ELISIO- H HEMODIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, niida-aza; ohdate-shi, akita; 018-5 794; JA 018-5794
• Manufacturer (Section G): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, niida-aza; ohdate-shi, akita; 018-5 794; JA 018-5794
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami 33172 ; 3055997174
• MDR Report Key: 7325109
• MDR Text Key: 101951964
• Report Number: 9610987-2018-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: ELISIO-25H
• Device Lot Number: 15J05E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/08/2018 Patient Sequence Number: 1