MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO DIALYZER, ELISIO-H (PP) (110-210)

Model Number ELISIO-19H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

Final investigation is still in progress.Initial investigation attached on retained samples.[investigation report (initial) (b)(4)].

Event Description

Patient had allergic reaction 30 minutes into dialysis treatment.Patient experienced low blood pressure and dyspnea.Staff administered 2l/min of oxygen, 160g of methylprednisolone, and polaramine due to allergic reaction.Nurse stated that patient has used the same kind of dialyzer in prior treatments and did not experience any symptoms.

Manufacturer Narrative

Final investigation is still in progress.Initial investigation attached on retained samples.10/17/18: added product expiration date, added codes, follow up investigation attached on retained samples only, sample was never returned by the customer.

Event Description

Patient had allergic reaction 30 minutes into dialysis treatment.Patient experienced low blood pressure and dyspnea.Staff administered 2l/min of oxygen, 160g of methylprednisolone, and polaramine due to allergic reaction.Nurse stated that patient has used the same kind of dialyzer in prior treatments and did not experience any symptoms.

• Brand Name: NIPRO DIALYZER, ELISIO-H (PP) (110-210)
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 7958165
• MDR Text Key: 123487944
• Report Number: 9610987-2018-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: ELISIO-19H
• Device Lot Number: 18B12B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention