• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIPRO CORPORATION (ODATE) NIPRO ELISIO-H DIALYZER Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNIPRO ELISIO-H DIALYZER
Type of DeviceDIALYZER
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 Key8203666
MDR Text Key131702977
Report Number9610987-2018-00014
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K131935
Number of Events Reported1
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 Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberELISIO-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 Received12/11/2018
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
-
-