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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO ELISIO-H HEMODIALYZER (PP) Back to Search Results
Model Number ELISIO 21H
Device Problem Biocompatibility (2886)
Patient Problems Itching Sensation (1943); Reaction (2414)
Event Date 09/13/2018
Event Type  Injury  
Event Description
Patient had an allergic reaction 2hours and 20 minutes after treatment was initiated. Patient experienced itchy sking and swelling of the tongue and lips. Treatment was stopped. Steroid and adrenal injection was administered, patient has been under the care of a cardiologist. Dialysis conditions: treatment time: 4hours, blood flow rate: 300, dialysate flow rate: 500, heparin volume: fraxiparine 0. 2. Dialysis machine used: fresenius 5008, bloodline: av-set online plus bvm 5008-r (f00000385), medtronic catheter: (model unknown).
 
Manufacturer Narrative
Investigation report attached on retained samples only. On 10/26/2018: investigation report attached on retained samples, final investigation report on returned sample is still in progress. (b)(4).
 
Event Description
Patient had an allergic reaction 2hours and 20 minutes after treatment was initiated. Patient experienced itchy sking and swelling of the tongue and lips. Treatment was stopped. Steroid and adrenal injection was administered, patient has been under the care of a cardiologist. Dialysis conditions: treatment time: 4hours, blood flow rate: 300, dialysate flow rate: 500, heparin volume: fraxiparine 0. 2 dialysis machine used: fresenius 5008, bloodline: av-set online plus bvm 5008-r (f00000385), medtronic catheter: (model unknown).
 
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Brand NameNIPRO ELISIO-H HEMODIALYZER (PP)
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key7992467
MDR Text Key124662482
Report Number9610987-2018-00011
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model NumberELISIO 21H
Device Lot Number17K13C
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/22/2018 Patient Sequence Number: 1
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