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

Model Number ELISIO-19H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Date 01/13/2019

Event Type  Injury  

Event Description

During a dialysis treatment, using a gambro machine and an elisio 19h dialyzer, about 10 min. Into the treatment, the patient developed a reaction, which was reflected in decreased blood pressure, feeling unwell and a desire to vomit. The blood was returned immediately to the patient, and the dialyzer was replaced to a fresenius dialyzer (fx100) and the treatment was continued. The patient continued not feeling well with the fx100 - low blood pressure and nausea, but the treatment was completed. Patient was sent to the er for observation and patient recovered. On (b)(6) 2019 the nurse at the dialysis unit, which also was present at the event, informed that this patient has previously responded not well to fresenius dialyzer (fx80), and was treated in the past with sureflux 19e. The patient has been on dialysis for the past 2 years. Dialysis conditions: dialysis treatment time: 3 1/2 hours; priming: 700ml normal saline; blood flow rate: 280ml/min; dialysate flow: 700ml/min. Other devices used: bloodline: gambro a252r-v777r.

• Brand Name: NIPRO ELISIO-H DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer (Section G): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 8322107
• MDR Text Key: 135699534
• Report Number: 9610987-2019-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2021
• Device Model Number: ELISIO-19H
• Device Lot Number: 18I27B
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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: 02/08/2019 Patient Sequence Number: 1