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

Model Number DD+CT17H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278)

Event Date 09/22/2018

Event Type  Injury  

Event 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).

• Brand Name: NIPRO CELLENTIA DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 8203353
• MDR Text Key: 131704045
• Report Number: 1056186-2018-00016
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DD+CT17H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2018
• Distributor Facility Aware Date: 12/18/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR