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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO ELISIO-H HEMODIALYZER (PP) (110-210) Back to Search Results
Model Number DD+ELISIO-19H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Reaction (2414)
Event Date 02/08/2017
Event Type  Injury  
Manufacturer Narrative
Investigation report attached includes product codes and dates of occurrences from different complaints received, lot numbers investigated are from representative samples randomly chosen by factory. Clinic(end user) did not retain lot number nor actual used sample for investigation. Distributor was unable to identify lot numbers shipped to this facility. Device not returned to manufacturer.
 
Event Description
Patient has been using elisio for a while (no exact date when patient started on elisio) and no reactions so far, but lately on (b)(6)2017 while on the treatment, rashes (red and itchy) noted on patient's face and upper extremities, went home and the next treatment there were still some rashes noted. Before treatment, dialyzer was flushed with 1l of saline and the symptoms improved. Patient was given an antihistamine (brand not given). This is the 2nd event in the clinic. This patient has psoriasis that makes it difficult to assess changes with skin condition. On 2/21/17: system primed with 350cc normal saline(50cc through the portion of the arterial line, and 300cc through the rest of the system), bfr (normal saline) during priming
=
100, machine ultra filtration system removed additional 150cc normal saline during prep cycle, and 350cc of normal saline were drained from the lines before the lines were connected to the patient. This is the usual priming procedure for the clinic. On 2/22/17: other devices used: bbraun dialysis machine, streamline blood tubing set, avf needle tulip ( these are usual devices used during treatment, no recent changes), no medications administered during treatment. Dialysis orders: bfr 300, dfr 600, ett(treatment time) 4hours, treatment continued and prescribed medrol dose pack,.
 
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Brand NameNIPRO ELISIO-H HEMODIALYZER (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 107th avenue
miami, FL 33172
3055997174
MDR Report Key6374395
MDR Text Key68966289
Report Number9610987-2017-00002
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDD+ELISIO-19H
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2017
Distributor Facility Aware Date02/20/2017
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/02/2017
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/02/2017 Patient Sequence Number: 1
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