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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER Back to Search Results
Model Number DD+CT17H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)
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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Brand NameNIPRO CELLENTIA DIALYZER
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer (Section G)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer Contact
michelle tejada
3150 nw 107 avenue
miami, FL 33172
3055997174
MDR Report Key8203581
MDR Text Key131704478
Report Number9610987-2018-00013
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2019
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?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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