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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO ELISIO- H HEMODIALYZER Back to Search Results
Model Number ELISIO-25H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Headache (1880); Local Reaction (2035); Weakness (2145); Numbness (2415)
Event Date 01/24/2018
Event Type  Injury  
Manufacturer Narrative
Investigation reports attached on retained samples and unused/unopened returned sample. (b)(4).
 
Event Description
After 20 minutes into dialysis treatment, using the nipro elisio eli 25 h dialyzer, the patient started to suffocate, feel weakness, headache, numbness of the mouth which required use of antihistamine. After stopping the dialysis, the patient was fine. Furthermore, patient was using previously other similar product from another manufacturer (b braun xevonta hi 23) without any complications.
 
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Brand NameNIPRO ELISIO- H HEMODIALYZER
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, niida-aza
ohdate-shi, akita
018-5 794
JA 018-5794
Manufacturer (Section G)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, niida-aza
ohdate-shi, akita
018-5 794
JA 018-5794
Manufacturer Contact
michelle tejada
3150 nw 107 avenue
miami 33172
3055997174
MDR Report Key7325109
MDR Text Key101951964
Report Number9610987-2018-00005
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Model NumberELISIO-25H
Device Lot Number15J05E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2015
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: 03/08/2018 Patient Sequence Number: 1
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