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

Model Number	DD+ELISIO-19H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the 2nd patient sent to the icu after dialysis treatment.No further information was provided.Unknown details of adverse event or patient symptoms.Clinical specialist will continue to attempt to obtain additional information.Additional information received 11/23/2020: patient (b)(6), a (b)(6)-year-old female, started dialysis treatment at 630am on (b)(6) 2020, set for 3.5h as ordered, bp 104/65; hr 97.Patient complained of heartburn during dialysis.Patient stated she has this occasionally at home and takes some meds for it.Renal physician notified of patient's complaints.Patient was started on oxygen 3l/nasal cannula due to complaints of shortness of breath.O2(oxygen) saturation checked, 100% with oxygen.Patient was resting during hd with no further distress.At approximately an hour and a half into treatment, renal physician was making rounds, seen and examined patient, with orders to stop hd, draw labs: cbc, lipase, troponin, electrolytes and sent to emergency room for further evaluation/treatment.Hd ended 2.5 hours into treatment.Needles were removed with no severe bleeding.Bp 118/68; hr 98; temp: 97.8.Treatment information: number of hours: 2.5 access; bfr: 400; dfr: 600; heparin: bolus; how long on dialysis: 2.5 hours into a 3.5 prescribed treatment.Dialyzer: elisio 19h dialyzer; machine: phoenix gambro.
Additional Manufacturer Narrative
Manufacturer investigation report attached is on retained samples only.
Event or Problem Description
On (b)(6) 2020: 2nd patient sent to the icu after dialysis treatment.No further information was provided.Unknown details of adverse event or patient symptoms.Clinical specialist will continue to attempt to obtain additional information.Additional information received 11/23/2020: patient (b)(6), 75-year-old female, started dialysis treatment at 630am on (b)(6) 2020, set for 3.5h as ordered, bp 104/65; hr 97.Patient complained of heartburn during dialysis.Patient stated she has this occasionally at home and takes some meds for it.Renal physician notified of patient's complaints.Patient was started on oxygen 3l/nasal cannula due to complaints of shortness of breath.O2 (oxygen) saturation checked, 100% with oxygen.Patient was resting during hd with no further distress.At approximately an hour and a half into treatment, renal physician was making rounds, seen and examined patient, with orders to stop hd, draw labs: cbc, lipase, troponin, electrolytes and sent to emergency room for further evaluation/treatment.Hd ended 2.5 hours into treatment.Needles were removed with no severe bleeding.Bp 118/68; hr 98; temp: 97.8.Treatment information: number of hours: 2.5 access.Bfr: 400.Dfr: 600.Heparin: bolus.How long on dialysis: 2.5 hours into a 3.5 prescribed treatment.Dialyzer: elisio 19h dialyzer.Machine: phoenix gambro.

• Brand Name: NIPRO ELISIO-H DIALYZER
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 10955687
• Report Number: 9610987-2020-00010
• Device Sequence Number: 11380100
• Product Code: KDI
• UDI-Device Identifier: 00383790007122
• UDI-Public: 00383790007122
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: DD+ELISIO-19H
• Device Catalogue Number: DD+ELISIO-21H
• Device Lot Number: 19K21B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/06/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: Hospitalization
• Patient Age: 75 YR