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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 Itching Sensation (1943); Nausea (1970); Swelling (2091); Vomiting (2144); Loss of consciousness (2418); Sweating (2444); Diminished Pulse Pressure (2606)
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative
There is no indication of a device malfunction. The cartridge was not returned for evaluation and a lot number was not provided. Without a lot number, a device history review (dhr) could not be performed. The device meets all quality criteria and manufacturing criteria and specifications prior to release. Biocompatibility has been established. The user guide and instructions for use include allergic reaction as a potential risk associated with dialysis treatments and also include 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 on (b)(6) 2018 from a healthcare professional regarding a (b)(6) female with a recent history of myocardial infarction and hypotension during conventional hemodialysis, who became symptomatic during their first short daily hemodialysis treatment using the involved device on (b)(6) 2018. Within ten minutes of commencing treatment, the patient began to feel itchy and had facial flushing with a blood pressure (bp) of 112/80 and heart rate (hr) of 110 beats per minute. An unspecified volume of saline was administered without improvement. The patient experienced additional symptoms including nausea and vomiting, which progressed to unresponsiveness, diaphoresis, lip swelling, fixed pupils and a blood pressure that could not be obtained. A further volume of saline (800ml) was administered with some improvement (bp 117/78, hr 33) and emergency services attended. The patient received two epipen injections, two doses of adrenaline (nos) and was hospitalized. She recovered without sequelae and received hemodialysis with a conventional hemodialysis device from another manufacturer on (b)(6) 2018 without issue.
 
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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 Key8010336
MDR Text Key125199524
Report Number3003464075-2018-00056
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 01/01/2005,10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
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 Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/26/2018 Patient Sequence Number: 1
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