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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-172-C
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
The device was not available for evaluation. A review of the device history record (dhr) was conducted which revealed the cartridge met all requirements and specifications prior to release. A review of the complaint database returned no other cases of this issue with this lot number. The nxstage system one user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received from a physician on (b)(6) 2018 regarding a (b)(6) male patient with a medical history of meningo-encephalitis and chronic tubular interstitial nephritis, who developed itchy, red macular skin lesions over all his body approximately 1 hr 30 mins into his first nxstage hemodialysis treatment on (b)(6) 2018. Dialysis was terminated and he was treated with 40mg intravenous solumedrol and an oral antihistamine (xyzall 5mg) after which symptoms resolved. The physician stated the patient had an allergy to the dialyzer. The patient resumed hemodialysis later the same day with a dialyzer from a different manufacturer.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9786874700
MDR Report Key7527040
MDR Text Key108682957
Report Number3003464075-2018-00022
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2019
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number71077038
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 Received05/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2017
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: 05/18/2018 Patient Sequence Number: 1
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