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

Model Number ELI-25H-PO-GI

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Malaise (2359); Diaphoresis (2452); Low Oxygen Saturation (2477)

Event Date 09/09/2020

Event Type  Injury  

Event Description

Patient experienced an allergic reaction 30-40 minutes into the hemodailysis treatment.Patient experienced malaise, profuse sweat, chest oppression, epigastric pain, dyspnea, and desaturation.The staff stopped the treatment.No blood restitution was required, patient lost approximately 300ml of blood.No medical actions were taken.The patient was reconnected using another dialyzer (baxter-pmma), no further issues occurred.No additional information was provided.

Manufacturer Narrative

On (b)(6) 2020: device evaluation attached is on retained samples only.

Event Description

Patient experienced an allergic reaction 30-40 minutes into the hemodailysis treatment.Patient experienced malaise, profuse sweat, chest oppression, epigastric pain, dyspnea, and desaturation.The staff stopped the treatment.No blood restitution was required, patient lost approximately 300ml of blood.No medical actions were taken.The patient was reconnected using another dialyzer (baxter-pmma), no further issues occurred.No additional information was provided.

• 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
• MDR Report Key: 10645604
• MDR Text Key: 210425220
• Report Number: 9610987-2020-00005
• 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: 10/13/2020

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 Expiration Date: 04/30/2023
• Device Model Number: ELI-25H-PO-GI
• Device Lot Number: 20E21E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other