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

Model Number ELISIO-21H

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Sepsis (2067)

Event Date 05/29/2022

Event Type  Injury  

Event Description

2 incidents with foreign patients, first time dialyzing in thailand: 10 minutes into dialysis treatment, patient's could not breath and found to have signs of shock.Physician decided to interrupt treatment and change dialyzer to a different brand (fdy).No additional information provided.Expected treatment time: 4hours, priming condition: 2000ml, bfr 200ml/min, blood flow rate 350ml/min, dialysate flow rate 800ml/min.Other devices used: fresenius dialysis machine and fmc 5008 bloodlines.

• Brand Name: NIPRO ELISIO-H DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer (Section G): NIPRO CORPORATION (ODT); 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 Key: 15092335
• MDR Text Key: 296468364
• Report Number: 9610987-2022-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ELISIO-21H
• Device Lot Number: 21I30C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other