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

Model Number	DD+ELISIO-25H
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Local Reaction (2035); Increased Sensitivity (2065)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During dialysis treatment, the patient complained of itchiness, redness was noticed at the back of her neck (2x2 cm).The facility administrator mentioned that maybe the reaction was from the new shirt the patient was wearing.Patient was able to complete the treatment, but when the patient reached home, the patient stated the itchiness worsened and noticed more redness on multiple areas.Dialysis treatment order: patient dialyzed 3.5 hrs, bfr = 500, dfr = 800.Heparin with 1000 units bolus and 1000 units/hr stop 1 hr before end of treatment.Meds administered: hectorol 1 mg and iron 125 mg (has been given these medications before without issues).Additional information received 6/19/2019: patient is doing good now with the elisio dialyzer, the staff is now priming with 1.5 l of saline and patient has not had any reactions during treatment.
Event or Problem Description
During dialysis treatment, the patient complained of itchiness, redness was noticed at the back of her neck (2x2 cm).The facility administrator mentioned that maybe the reaction was from the new shirt the patient was wearing.Patient was able to complete the treatment, but when the patient reached home, the patient stated the itchiness worsened and noticed more redness on multiple areas.Dialysis treatment order: patient dialyzed 3.5 hrs, bfr = 500, dfr = 800.Heparin with 1000 units bolus and 1000 units/hr stop 1 hr before end of treatment.Meds administered: hectorol 1 mg and iron 125 mg (has been given these medications before without issues).Additional information received 6/19/19: patient is doing good now with the elisio dialyzer, the staff is now priming with 1.5 l of saline and patient has not had any reactions during treatment.
Additional Manufacturer Narrative
Investigation report is on retained samples only.(b)(4).

• Brand Name: NIPRO DIALYZER ELISIO-H (PP)
• 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: 8750934
• Report Number: 9610987-2019-00005
• Device Sequence Number: 2398219
• Product Code: KDI
• UDI-Device Identifier: 00383790007139
• UDI-Public: 00383790007139
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140191
• 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): 07/16/2019
• Report Date (Section F): 07/01/2019

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: 11/30/2021
• Device Model Number: DD+ELISIO-25H
• Device Lot Number: 18L27E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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
• Date Report Sent to FDA: 07/01/2019