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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO ELISIO-H DIALYZER Back to Search Results
Model Number ELISIO-25H
Device Problem Fluid Leak (1250)
Patient Problems Discomfort (2330); Malaise (2359)
Event Date 07/21/2020
Event Type  Injury  
Event Description
During hemodialysis treatment session, the patient complained of not feeling well. The nurse noticed a blood leakage. Treatment was interrupted and the patient was sent to the emergency room. Pending additional details from the customer.
 
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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 Key10529229
MDR Text Key206792400
Report Number9610987-2020-00004
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 foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberELISIO-25H
Device Catalogue NumberELI-25H-PO-GJ
Device Lot Number20D02E
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 Received08/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2020
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: 09/14/2020 Patient Sequence Number: 1
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