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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 DD+ELISIO-15H
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Rash (2033); Loss of consciousness (2418); Low Oxygen Saturation (2477)
Event Type  Injury  
Event Description
On june 29, 2018 the manufacturer was advised of an adverse event that occurred in (b)(6) 2016 (exact date unknown), while using a dialyzer model that was not similar to any model sold in the united states. Complaint details: the patient was using a cta dialyzer and she was changed to nipro pes dialyzer. After the change, the patient had deterioration of the skin and itching. On (b)(6) of 2017, after initiation of treatment, the patient's blood pressure and oxygen level decreased. The patient was hospitalized, had fever and skin rash with increasing eosinophils and high level of ige. Allergy to pes dialyzer was suspected. The dialyzer was changed to the cta dialyzer. Dialysis was then completed without symptoms. Eosinophils and ige levels decreased, skin itching was improved. The patient was then discharged from the hospital, dialysis has continued to be stable using the cta dialyzer. On september 28, 2018, the manufacturer was advised that the product code reported was incorrect. Once corrected, it was determined that the correct code has a similar model sold in the united states. Mdr reportability was then initiated.
 
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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, 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 Key7927938
MDR Text Key122452858
Report Number9610987-2018-00009
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDD+ELISIO-15H
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 Received09/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2017
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: 10/02/2018 Patient Sequence Number: 1
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