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

Model Number ELISIO-25H

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914)

Event Date 09/23/2020

Event Type  Injury  

Event Description

30 minutes into hemodialysis treatment, patient began experiencing allergic reactions.Symptoms were tightness of the ches, hypotension, and impression of asphyxiation.Patient has been using the nipro elisio hemodialyzers since 2019 without reactions.Patient's blood pressure level was 70/40 with a 95% saturation level.Patient recovered soon after.Next treatment on (b)(6) 2020, using pmma (bg) dialyzer without complications.No sample was available.Dialysis machine used: fresenius 5008.

Event Description

30 minutes into hemodialysis treatment, patient began experiencing allergic reactions.Symtptoms were tightness of the ches, hypotension, and impression of asphyxiation.Patient has been using the nipro elisio hemodialyzers since 2019 without reactions.Patient's blood pressure level was 70/40 with a 95% saturation level.Patient recovered soon after.Next treatment on (b)(6) 2020, using pmma (bg) dialyzer without complications.No sample was available.Dialysis machine used: fresenius 5008.

• Brand Name: NIPRO ELISIO-H HEMODIALYZER
• 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: 10766925
• MDR Text Key: 214147189
• Report Number: 9610987-2020-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: ELISIO-25H
• Device Catalogue Number: ELI-25H-PO-GJ
• Device Lot Number: 19L12E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other