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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-170-C
Device Problem Leak/Splash (1354)
Patient Problems Bacterial Infection (1735); Fever (1858); Sepsis (2067); Chills (2191)
Event Date 02/02/2017
Event Type  Injury  
Manufacturer Narrative
The cartridge was not returned for evaluation. A lot number was not provided. Without a lot number, a device history review (dhr) could not be performed. An evaluation of the cartridge was not possible. Biocompatibility has been established. There is no information to indicate that a malfunction occurred. The nxstage user guide provides warning to always use aseptic technique when handling connections. Touching these surfaces may make them non-sterile, which may cause patient infection. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 17-apr-2017 regarding (b)(6), a (b)(6) male patient with unknown comorbidities who experienced sepsis. The patient was receiving standard home hemodialysis treatment on (b)(6) 2017. During treatment, a leak was noted in the dialysate line of the cartridge. On (b)(6) 2017 the patient reported fever and chills with a temperature of 103 f. The patient was hospitalized from (b)(6) 2017. The patient was treated with daily antibiotics (ceftriaxone 2g) while in the hospital and continued until (b)(6) 2017. The discharge diagnosis from the hospital was streptococcus sepsis.
 
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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 Key6547037
MDR Text Key74490351
Report Number3003464075-2017-00028
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
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 05/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
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 Received04/17/2017
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 Initial

Patient Treatment Data
Date Received: 05/05/2017 Patient Sequence Number: 1
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