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

Model Number	DD+ELISIO-15H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
15 minutes into a 3.5 hrs dialysis treatment, machine alarmed for blood leak.Blood leak was confirmed with a positive blood leak test strip.Patient's blood was not returned, lost approximately 150ml of blood.Patient was in good condition and did not require any additional medications, a new machine was set up.Patient was able to complete their dialysis treatment.Present hemoglobin was 11.3.Dialysis conditions: primed with bfr of 100ml/hr with 300ml volume.Treatment time is 3.5 hrs, 400 bfr, 600 dfr.Medications: zemplar 6mcg.Vascular access: right (avf) arterial venous fistula.Other devices used: fresenius dialysis machine, streamline bloodlines, masterguard.
Additional Manufacturer Narrative
9/16/19: investigation report attached is on retained samples only.
Event or Problem Description
15 minutes into a 3.5hrs dialysis treatment, machine alarmed for blood leak.Blood leak was confirmed with a positive blood leak test strip.Patient's blood was not returned, lost approximately 150ml of blood.Patient was in good condition and did not require any additional medications, a new machine was set up.Patient was able to complete their dialysis treatment.Present hemoglobin was 11.3.Dialysis conditions: primed with bfr of 100ml/hr with 300ml volume.Treatment time is 3.5hrs, 400 bfr, 600 dfr.Medications: zemplar 6mcg.Vascular acess: right (avf) arterial venous fistula.Other devices used: fresenius dialysis machine, streatmline bloodlines, masterguard.

• Brand Name: NIPRO ELISIO-H DIALYZER
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 8994592
• Report Number: 9610987-2019-00010
• Device Sequence Number: 3169223
• Product Code: KDI
• UDI-Device Identifier: 40383790007106
• UDI-Public: 40383790007106
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DD+ELISIO-15H
• Device Lot Number: 19C25F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention