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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).
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Type of DeviceDIALYZER
Manufacturer (Section D)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key8203353
MDR Text Key131704045
Report Number1056186-2018-00016
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDD+CT17H
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2018
Distributor Facility Aware Date12/18/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer12/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1