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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 Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/22/2021
Event Type  Injury  
Manufacturer Narrative
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. Biocompatibility of the device has been established.
 
Event Description
A report was received on 22 jun 2021 from the home therapy nurse (htn) of a (b)(6) year old female patient with a complex medical history including end stage renal disease, who stated the patient experienced an allergic reaction (nos) approximately twenty minutes into her second in-center hemodialysis treatment on (b)(6) 2021 and was transported to hospital. Additional information was received on 23 jun 2021 from the htn who stated, the patient symptoms included itchy rash around the left bicep, ¿small hives¿, muffled voice, being ¿colder than normal" and hypotension (98 mmhg systolic). Htn administered 100 ml of normal saline and benadryl 50 mg intravenous (iv), terminating treatment without rinseback. The patient then had trouble swallowing and was given iv solu-medrol 125 mg and subcutaneous adrenaline 0. 2 ml. Systolic blood pressure decreased to ~80 mmhg, an additional 200 ml normal saline was administered and emergency medical services (ems) were called, who transported the patient to hospital. Following a period of observation at the emergency room of approximately three hours, the patient was released same day in stable condition with symptoms significantly improved. Per the htn, the patient has recovered without sequelae and will resume treatment using the nxstage system with an alternate cartridge type.
 
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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
MDR Report Key12069695
MDR Text Key259589763
Report Number3003464075-2021-00030
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 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
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
Device Lot Number10477083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2021
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: 06/25/2021 Patient Sequence Number: 1
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