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

Model Number DD+ELISIO-15H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Rash (2033); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

On june 29, 2018 the manufacturer was advised of an adverse event that occurred in (b)(6) 2016 (exact date unknown), while using a dialyzer model that was not similar to any model sold in the united states.Complaint details: the patient was using a cta dialyzer and she was changed to nipro pes dialyzer.After the change, the patient had deterioration of the skin and itching.On (b)(6) of 2017, after initiation of treatment, the patient's blood pressure and oxygen level decreased.The patient was hospitalized, had fever and skin rash with increasing eosinophils and high level of ige.Allergy to pes dialyzer was suspected.The dialyzer was changed to the cta dialyzer.Dialysis was then completed without symptoms.Eosinophils and ige levels decreased, skin itching was improved.The patient was then discharged from the hospital, dialysis has continued to be stable using the cta dialyzer.On september 28, 2018, the manufacturer was advised that the product code reported was incorrect.Once corrected, it was determined that the correct code has a similar model sold in the united states.Mdr reportability was then initiated.

Manufacturer Narrative

Evaluation attached completed on retained samples only.

Event Description

On (b)(6)2018 the manufacturer was advised of an adverse event that occurred in june 2016 (exact date unknown), while using a dialyzer model that was not similar to any model sold in the united states.Complaint details: the patient was using a cta dialyzer and she was changed to nipro pes dialyzer.After the change, the patient had deterioration of the skin and itching.On november of 2017, after initiation of treatment, the patient's blood pressure and oxygen level decreased.The patient was hospitalized, had fever and skin rash with increasing eosinophils and high level of ige.Allergy to pes dialyzer was suspected.The dialyzer was changed to the cta dialyzer.Dialysis was then completed without symptoms.Eosinophils and ige levels decreased, skin itching was improved.The patient was then discharged from the hospital, dialysis has continued to be stable using the cta dialyzer.On (b)(6)2018 , the manufacturer was advised that the product code reported was incorrect.Once corrected, it was determined that the correct code has a similar model sold in the united states.Mdr reportability was then initiated.

• Brand Name: NIPRO DIALYZER - ELISIO-H (PP) (110-210)
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, niida-aza; ohdate-shi, akita; 018-5 794; JA 018-5794
• MDR Report Key: 7927938
• MDR Text Key: 122452858
• Report Number: 9610987-2018-00009
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 40383790007090
• UDI-Public: 40383790007090
• 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
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DD+ELISIO-15H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 44