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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION USD XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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NIPRO CORPORATION USD XENIUM XPH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number H25601A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Reaction (2414)
Event Date 03/02/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A hemodialysis patient experienced a rash which occurred following treatment after using a xenium dialyzer. The patient was treated with loratadine (dose, route, frequency and duration not reported). The filter was changed, therapy end regularly and the patient was discharged. No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameXENIUM XPH
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NIPRO CORPORATION USD
ohdate-shi
Manufacturer (Section G)
NIPRO CORPORATION USD
8-7 hanukiyachi, niida-aza
odate-shi
JA
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6435440
MDR Text Key70878796
Report Number1416980-2017-02658
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K083778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 05/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberH25601A
Device Lot Number15H27A
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 Received04/28/2017
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

Patient Treatment Data
Date Received: 03/27/2017 Patient Sequence Number: 1
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