MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZER (90, 250)

Model Number ELISIO-25H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)

Event Date 03/12/2021

Event Type  Injury  

Event Description

Patient complained of respiratory discomfort 30 minutes after the start of dialysis treatment.The blood pressure dropped to 70 and spo2 became 87%.Oxygen was administered.Actual lot number is unknown.Possible lot numbers 20l10e or 21a21e.No further information was provided.

• Brand Name: NIPRO ELISIO-H DIALYZER (90, 250)
• 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: 11676059
• MDR Text Key: 261691423
• Report Number: 9610987-2021-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ELISIO-25H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/15/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other