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

Model Number	DD+CT17H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Reaction (2414)
Date of Event	09/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinic manager reported a patient who had dialyzer reactions on unspecified dates since (b)(6) 2018.Patient's first dialysis was (b)(6) 2018.No reactions were encountered between (b)(6) 2018 and (b)(6) 2018.Patient was using the optiflux 180nre.The clinic manager first thought the reaction was due to the gloves, gloves were changed and the patient continued to have allergic reaction.Dialyzer was then changed to the optiflux 180nr, but the patient continued to have allergic reaction.The clinic manager then changed to the nipro cellentia 17h on (b)(6) 2018, the patient reportedly had a few small hives and slight itching during mid-treatment to last hour of treatment.The clinic manager confirmed that the dialyzer was flushed with normal saline solution prior to treatment, priming flushing dialyzer with 2 liter nss every treatment per physician orders and confirmed that benadryl was administered to the patient intravenously both pre-treatment and mid-treatment.The clinic manager confirmed the patient completed their treatments, and confirmed the patient's symptoms resolve after treatment is completed.Lot numbers were not recorded.Patient continues to have reaction but is improved in severity to mild, patient no longer has break out of blistering hives while using the cellentia.There have been no known changes in any products used during dialysis.Usual dialysis medications are given (iv iron, engerix, calcitriol, heparin) current medications are heparin and prn meds (zofran, tylenol, dextrose).Patient has not had any changes in medications.Dialysis order: tue/thur/sat; 4hrs treatment, bfr 450, dfr autoflow, dialysate 2.0 k, 2.5 ca, 1.0mg, 100 dextrose, sodiu, 140(meq/l), bicarb setting: 36(meq/l).
Event or Problem Description
Clinic manager reported a patient who had dialyzer reactions on unspecified dates since (b)(6) 2018.Patient's first dialysis was (b)(6) 2018.No reactions were encountered between (b)(6) 2018.Patient was using the optiflux 180nre.The clinic manager first thought the reaction was due to the gloves, gloves were changed and the patient continued to have allergic reaction.Dialyzer was then changed to the optiflux 180nr, but the patient continued to have allergic reaction.The clinic manager then changed to the nipro cellentia 17h on (b)(6) 2018, the patient reportedly had a few small hives and slight itching during mid-treatment to last hour of treatment.The clinic manager confirmed that the dialyzer was flushed with normal saline solution prior to treatment, priming flushing dialyzer with 2 liter nss every treatment per physician orders and confirmed that benadryl was administered to the patient intravenously both pre-treatment and mid-treatment.The clinic manager confirmed the patient completed their treatments, and confirmed the patient's symptoms resolve after treatment is completed.Lot numbers were not recorded.Patient continues to have reaction but is improved in severity to mild, patient no longer has break out of blistering hives while using the cellentia.There have been no known changes in any pruducts used during dialysis.Usual dialysis medications are given (iv iron, engerix, calcitriol, heparin) current medications are heparin and prn meds (zofran, tylenol, dextrose).Patient has not had any changes in medications.Dialysis order: tue/thur/sat; 4hrs treatment, bfr 450, dfr autoflow, dialysate 2.0 k, 2.5 ca, 1.0mg, 100 dextrose, sodiu, 140(meq/l), bicarb setting: 36(meq/l),.
Additional Manufacturer Narrative
Investigation report attached is on representative retained samples since the customer did not provide a lot number related to the event.

• 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: 8203581
• Report Number: 9610987-2018-00013
• Device Sequence Number: 16212419
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160444
• 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): 01/11/2019

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 Model Number: DD+CT17H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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 Age: 68 YR