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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 Dyspnea (1816); Tingling (2171); Shaking/Tremors (2515)
Event Date 06/06/2019
Event Type  Injury  
Manufacturer Narrative
The involved cartridge was not returned for evaluation. A review of the device history record (dhr) was conducted which confirmed that the product met 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 07 jun 2019 from the physician regarding a (b)(6) male, with a recent history of respiratory difficulty during hemodialysis treatment, who experienced respiratory difficulty, chest pain, tremor, and tingling lips at the time of connection during their second hemodialysis treatment with the nxstage system on (b)(6) 2019. Additional information was received on (b)(6) 2019 from a pharmacist stating treatment was terminated after approximately 50 minutes and the patient was treated with oral polaramine (dose unspecified). The patient recovered without sequelae and has discontinued receiving hemodialysis treatment using nxstage product and therapy.
 
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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 Key8723520
MDR Text Key148818005
Report Number3003464075-2019-00029
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2019
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number80277035
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 Received06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/21/2019 Patient Sequence Number: 1
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