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

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).

Manufacturer Narrative

Investigation report attached on retained samples only.(b)(6)2018 : investigation report attached on retained samples, final investigation report on returned sample is still in progress.(b)(6)2018 : date of device(actual used) returned to manufacturer is unknown, final investigation report attached is on actual used device.

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.).

• Brand Name: NIPRO ELISIO-H HEMODIALYZER (PP)
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 7992467
• MDR Text Key: 124662482
• Report Number: 9610987-2018-00011
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• 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 Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: ELISIO 21H
• Device Lot Number: 17K13C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 49