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

Model Number	DD+ELISIO-15H
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation report still in progress.
Event or Problem Description
27 min into the dialysis treatment, the machine alarmed for minor blood leak, the staff tested it with a blood leak test strip and results were positive.They were unable to return the patient's blood, the machine was switched, and while setting up new dialyzer and bloodlines, the patient infiltrated and could not restart treatment.Patient left the dialysis unit stable, temperature was 96.5 right after machine alarmed for blood leak, temperature was 96.4 when discharged from unit.Since the staff was unable to return the patient's blood, 300ml of blood was lost.Patient's physician and clinical coordinator were aware of the issue.Physician increased dose of venofer and order to recheck hemoglobin level on next scheduled treatment.Patient's regular dialysis treatment was rescheduled for (b)(6) 2018 due to infiltration, staff was unable to draw labs.Patient is being scheduled for vascular access intervention (angioplasty) on (b)(6) 2018.Treatment was started at 6:07am and medication was given at 6:28am.Patient's access is a left upper av fistula.Treatment orders: 210 mins treatment, 3k, 2.5ca, bicrab 32, sodium 138, bfr 400, dfr 600, heparin bolus 2000 units and 600 units/hour, medication - epogen 10,000 units ivp, venofer order was 50mg weekly on that day ivp, hectorol 3.5mcg ivp and zone bar po.Other devices used: fresenius 2008 k2 dialysis machine.
Additional Manufacturer Narrative
Investigation report still in progress.(b)(4).
Event or Problem Description
27 min into the dialysis treatment, the machine alarmed for minor blood leak, the staff tested it with a blood leak test strip and results were positive.They were unable to return the patient's blood, the machine was switched, and while setting up new dialyzer and bloodlines, the patient infiltrated and could not restart treatment.Patient left the dialysis unit stable, temperature was 96.5 right after machine alarmed for blood leak, temperature was 96.4 when discharged from unit.Since the staff was unable to return the patient's blood, 300ml of blood was lost.Patient's physician and clinical coordinator were aware of the issue.Physician increased dose of venofer and order to recheck hemoglobin level on next scheduled treatment.Patient's regular dialysis treatment was rescheduled for (b)(6) 2018 due to infiltration, staff was unable to draw labs.Patient is being scheduled for vascular access intervention (angioplasty) on (b)(6) 2018.Treatment was started at 6:07 am and medication was given at 6:28 am.Patient's access is a left upper av fistula.Treatment orders: 210 mins treatment, 3k, 2.5ca, bicrab 32, sodium 138, bfr 400, dfr 600, heparin bolus 2000 units and 600 units/hour, medication - epogen 10,000 units ivp, venofer order was 50 mg weekly on that day ivp, hectorol 3.5 mcg ivp and zone bar po.Other devices used: fresenius 2008 k2 dialysis machine.

• 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: 8202384
• Report Number: 9610987-2018-00012
• Device Sequence Number: 233866
• Product Code: KDI
• UDI-Device Identifier: 00383790007092
• UDI-Public: 00383790007092
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 01/31/2021
• Device Model Number: DD+ELISIO-15H
• Device Lot Number: 18B22F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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
• Patient Weight: 85