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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyanosis (1798); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Low Oxygen Saturation (2477)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
No cartridge was returned for evaluation and a lot number was not provided. The product meets all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions. Biocompatability has been established. This report and the information contained herein is submitted to the applicable competent authority under medical device directive 93/42/eec and represents the information available to the company at the time of the report.
 
Event Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) regarding a (b)(6) female with a medical history significant for autoimmune hemolytic anemia, splenectomy, sepsis, grand mal seizures and an intraventricular hemorrhage, who became symptomatic ¿immediately after¿ initiating her first hemodialysis treatment with the nxstage system (b)(6) 2019. Symptoms included decreased oxygen saturation with cyanosis evident in the fingernails, a decrease in blood pressure, flushed skin and nausea which resolved after approximately an hour with administration of nasal oxygen. No other treatment was required. Additional information received on (b)(6) 2019 from the htn indicated the patient recovered without sequelae and continued to perform therapy with the nxstage system.
 
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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
9784505276
MDR Report Key8655879
MDR Text Key146618874
Report Number3003464075-2019-00018
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received05/04/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/30/2019 Patient Sequence Number: 1
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