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

Model Number ELISIO-25H

Device Problem Fluid/Blood Leak (1250)

Patient Problems Discomfort (2330); Malaise (2359)

Event Date 07/21/2020

Event Type  Injury  

Event Description

During hemodialysis treatment session, the patient complained of not feeling well.The nurse noticed a blood leakage.Treatment was interrupted and the patient was sent to the emergency room.Pending additional details from the customer.

Event Description

During hemodialysis treatment session, the patient complained of not feeling well.The nurse noticed a blood leakage.Treatment was interrupted and the patient was sent to the emergency room.Pending additional details from the customer.On 10/26/2020: according to the customer, the blood leakage was noticed from the dialyzer headers.Incident occured 1hr 15 minutes into 4 hour treatment.The machine did not alarm for blood leak.Patient lost about 1 liter of blood.No medical actions were taken.No further patient information was provided.Used sample was not available.Blood flow: 400 ml/min.Dialysate flow: 500 ml/min.Heparin volume: 0.30mg at the departure, second heparin dose was not given.Dialysis machine: bellco hemodialysis machine.

Manufacturer Narrative

On (b)(6) 2020: final investigation report attached is on retained samples only.

• 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: 10529229
• MDR Text Key: 206792400
• Report Number: 9610987-2020-00004
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: ELISIO-25H
• Device Catalogue Number: ELI-25H-PO-GJ
• Device Lot Number: 20D02E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 65