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

Model Number	DD+ELISIO-15H
Health Effect - Clinical Codes	Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
With 2 hours left of dialysis treatment, staff noticed that blood was visible on the arterial hanson dialysate line.Treatment was stopped and terminated immediately, blood was not returned.The dialysis machine was pulled out of the hospital unit floor and no new set up was started.Patient had shortness of breath, but staff was not sure if the patient had these symptoms prior to treatment.Treatment info: time = 4 hrs.Bfr/dfr = 300/600.Heparin = got 1900 units during treatment (didn't specify if it's bolus/maintenance).No other medications during treatment.Has cvc.Using gambro machine.5th treatment on elisio.Additional information received 03/30/2020: cause of patient death was natural; per coroner.Blood cultures were obtained and negative on day of event.Patient had multiple comorbidities including chf (congestive heart failure) with reduced ejection fraction, af(arterial fibrillation) with rvr(rapid ventricular rate), ckd(chronic kidney disease), and obesity.He did not tolerate hd due primarily to hypotension on treatment with inability to remove fluid and was massively fluid overloaded.Patient did not wish to pursue dialysis, and chose a comfort based approach after a trial of hd.He was imminently dying and family was supportive of his decision to pursue comfort/hospice care.

• 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: 9935741
• Report Number: 1056186-2020-00003
• Device Sequence Number: 19442360
• Product Code: KDI
• UDI-Device Identifier: 00383790007108
• UDI-Public: 00383790007108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020
• Report Date (Section F): 04/07/2020

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: 11/30/2020
• Device Model Number: DD+ELISIO-15H
• Device Catalogue Number: DD+ELISIO-17H
• Device Lot Number: 17L18F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2020
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2020
• 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
• Date Report Sent to FDA: 04/07/2020