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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278); Reaction (2414); Chest Tightness/Pressure (2463)
Event Date 07/26/2019
Event Type  Injury  
Manufacturer Narrative
The involved cartridge was not received 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.
 
Event Description
A report was received on (b)(6) 2019 from the nurse of a (b)(6) year old female patient with multiple comorbidities and a medical history significant for hypersensitivity type reactions during hemodialysis therapy, who became symptomatic approximately 15 minutes into a standard hemodialysis treatment on (b)(6) 2019. Symptoms including itching, hives, shortness of breath, and chest tightness. Oral benadryl (nos) and 2l nasal oxygen were given and the patient was transported to hospital receiving 324mg aspirin, and 1 round of duoneb en-route for wheezing; solumedrol and famotidine after arrival (doses not provided). The patient was evaluated in the emergency room (er), cxr and laboratory results were unremarkable. The patient recovered without sequelae and was released same day in stable condition.
 
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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 Key8856180
MDR Text Key153138129
Report Number3003464075-2019-00035
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
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 01/01/2005,08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2020
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number90477041
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 Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/02/2019 Patient Sequence Number: 1
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