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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) DIALYZER ELISIO-H Back to Search Results
Model Number ELI-25H-PO-GJ
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Dyspnea (1816)
Event Date 02/19/2019
Event Type  Injury  
Event Description
After 2 hours into hemodialysis treatment, patient started experiencing dyspnea(shortness of breath). The staff stopped the treatment, returned the patient's blood, changed the dialyzer to another type / brand (bg thoray) while using the same dialysis machine, continued treatment. Patient recovered immediately.
 
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Brand NameDIALYZER ELISIO-H
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 Key8432879
MDR Text Key139211823
Report Number9610987-2019-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K140191
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
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberELI-25H-PO-GJ
Device Lot Number18F28E
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 Received02/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/19/2019 Patient Sequence Number: 1
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