• 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 Patient-Device Incompatibility (2682)
Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970)
Event Date 01/13/2019
Event Type  Injury  
Event Description
During a dialysis treatment, using a gambro machine and an elisio 19h dialyzer, about 10 min. Into the treatment, the patient developed a reaction, which was reflected in decreased blood pressure, feeling unwell and a desire to vomit. The blood was returned immediately to the patient, and the dialyzer was replaced to a fresenius dialyzer (fx100) and the treatment was continued. The patient continued not feeling well with the fx100 - low blood pressure and nausea, but the treatment was completed. Patient was sent to the er for observation and patient recovered. On (b)(6) 2019 the nurse at the dialysis unit, which also was present at the event, informed that this patient has previously responded not well to fresenius dialyzer (fx80), and was treated in the past with sureflux 19e. The patient has been on dialysis for the past 2 years. Dialysis conditions: dialysis treatment time: 3 1/2 hours; priming: 700ml normal saline; blood flow rate: 280ml/min; dialysate flow: 700ml/min. Other devices used: bloodline: gambro a252r-v777r.
 
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 Key8322107
MDR Text Key135699534
Report Number9610987-2019-00002
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
Type of Report Initial
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Model NumberELISIO-19H
Device Lot Number18I27B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2018
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: 02/08/2019 Patient Sequence Number: 1
-
-