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

Model Number ELISIO-19H

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Shock (2072); Loss of consciousness (2418)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Final investigation still in progress.

Event Description

After completion of dialysis treatment, patient went into severe shock. Patient was given fluids and the blood was returned. Patient was stabilized and sent to the er for observation. Blood tests were performed and patient had low sodium levels. Patient recovered and was discharged. Patient returned to scheduled dialysis treatment at the dialysis unit without further complications. Preliminary inquiry shows that during the event the dialysis machine was immediately checked by a qualified technician who found no evidence of any fault. End user did not record the lot number for the device involved, but advised there could be two possible lot number: lot# 18h27b, manufactured: 8/27/2018, expiration: 07/31/2021; lot# 18h06b, manufactured: 08/06/2018, expiration: 07/31/2021.

• Brand Name: NIPRO ELISIO-H DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer (Section G): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 8203666
• MDR Text Key: 131702977
• Report Number: 9610987-2018-00014
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ELISIO-19H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/28/2018 Patient Sequence Number: 1