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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO DIALYZER, ELISIO-H (PP) (110-210)

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NIPRO CORPORATION (ODATE) NIPRO DIALYZER, ELISIO-H (PP) (110-210) Back to Search Results
Model Number ELISIO-19H
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
Event Date 09/25/2018
Event Type  Injury  
Manufacturer Narrative
Final investigation is still in progress. Initial investigation attached on retained samples. [investigation report (initial) (b)(4)].
 
Event Description
Patient had allergic reaction 30 minutes into dialysis treatment. Patient experienced low blood pressure and dyspnea. Staff administered 2l/min of oxygen, 160g of methylprednisolone, and polaramine due to allergic reaction. Nurse stated that patient has used the same kind of dialyzer in prior treatments and did not experience any symptoms.
 
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Brand NameNIPRO DIALYZER, ELISIO-H (PP) (110-210)
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer (Section G)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer Contact
michelle tejada
3150 nw 107 avenue
miami, FL 33172
3055997174
MDR Report Key7958165
MDR Text Key123487944
Report Number9610987-2018-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Model NumberELISIO-19H
Device Lot Number18B12B
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 Received09/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2018
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: 10/11/2018 Patient Sequence Number: 1
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