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

Model Number	DD+ELISIO-21H
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation report attached is on retained samples only.Actual used devices were returned, final investigation still in progress.(b)(4).
Event or Problem Description
Machine alarmed for blood leak 15 minutes into dialysis treatment, blood leak test strip was positive, treatment stopped and blood was not returned, patient lost about 200ml of blood.New machine set up was started, 5 minutes into dialysis treatment machine alarmed for blood leak again and tested blood leak test strip was positive, treatment was stopped, blood was not returned, patient lost about 200ml of blood again, a third machine set up was started again, patient finished treatment without further problems.Same dialzyer lot number was used for all 3 machine set ups.Since the blood leak alarms, patient has returned for their scheduled dialysis treatments without complications.Dialysis treatment order: 400 blood flow rate, 800 dialysate flow rate , treatment time 4hrs and 30min.Other devices used: dialysis machine: fresenius t, bloodlines: streamline.
Additional Manufacturer Narrative
Investigation report attached is on retained samples only.Actual used devices were returned, final investigation still in progress.(b)(6)2019 : investigation report attached is on actual used device.
Event or Problem Description
Machine alarmed for blood leak 15 minutes into dialysis treatment, blood leak test strip was positive, treatment stopped and blood was not returned, patient lost about 200ml of blood.New machine set up was started, 5 minutes into dialysis treatment machine alarmed for blood leak again and tested blood leak test strip was positive, treatment was stopped, blood was not returned, patient lost about 200ml of blood again, a third machine set up was started again, patient finished treatment without further problems.Same dialzyer lot number was used for all 3 machine set ups.Since the blood leak alarms, patient has returned for their scheduled dialysis treatments without complications.Dialysis treatment order: 400 blood flow rate, 800 dialysate flow rate , treatment time 4hrs and 30min.Other devices used: dialysis machine: fresenius t bloodlines: streamline.

• 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: 8356034
• Report Number: 9610987-2019-00001
• Device Sequence Number: 13877479
• Product Code: KDI
• UDI-Device Identifier: 00383790007122
• UDI-Public: 00383790007122
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 07/31/2021
• Device Model Number: DD+ELISIO-21H
• Device Lot Number: 18H20E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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: Required Intervention