MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER

Model Number	DD+CT19H
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Local Reaction (2035); Increased Sensitivity (2065)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
1 hour into dialysis treatment, the patient complained of itchiness and hives were noted on both lower and upper extremities and back.No benadryl was given and treatment was discontinued after 2 hrs of treatment, staff stated itchiness was better but redness still visible and patient was sent home.Patient will return on (b)(6) 2019 and will be put on rexeed dialyzer, which was the dialyzer she was previously using.The physician stated they will give the patient a week rest and will try again next (b)(6) 2019 on elisio dialyzer again but will prime the elisio with more saline (1.5 l), as they already prime the elisio 25h with 1 l of saline.Patient was given aranesp 40 mcg, hectorol 1 mcg and iron 125 mg during treatment, which are not new medications for her.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.Additional information received (b)(6) 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.This is the same patient that had a reaction to elisio (b)(6) 2019 ((b)(4)).
Event or Problem Description
1 hour into dialysis treatment, the patient complained of itchiness and hives were noted on both lower and upper extremities and back.No benadryl was given and treatment was discontinued after 2 hrs of treatment, staff stated itchiness was better but redness still visible and patient was sent home.Patient will return on saturday june 8, 2019 and will be put on rexeed dialyzer, which was the dialyzer she was previously using.The physician stated they will give the patient a week rest and will try again next thursday (6/13/19) on elisio dialzyer again but will prime the elisio with more saline (1.5 l), as they already prime the elisio 25h with 1 l of saline.Patient was given aranesp 40 mcg, hectorol 1 mcg and iron 125 mg during treatment, which are not new medications for her.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.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.**** this is the same patient that had a reaction to elisio 6/4/19 (comp# 190050_mdr7)****.

• Brand Name: NIPRO CELLENTIA 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: 8750977
• Report Number: 9610987-2019-00006
• Device Sequence Number: 2155141
• 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: K160444
• 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: 03/31/2022
• Device Model Number: DD+CT19H
• Device Lot Number: 19D01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 2 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