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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-500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Reaction (2414); Low Oxygen Saturation (2477)
Event Date 01/08/2021
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. The instructions for use warn that the device must be used under the prescription of a physician. 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. The patient¿s blood pressure, vital signs, general well-being, and physical status should be monitored closely throughout the treatment. Biocompatability has been established.
 
Event Description
A report was received on (b)(6) 2021 from the nurse of a (b)(6) old female in the critical care unit status post cardiac arrest with cardiogenic shock including hypotension requiring vasoactive medications, who stated the patient experienced tachycardia and hypotension approximately five minutes into their first continuous renal replacement therapy (crrt) session on (b)(6) 2021. Additional information was received on 12 jan 2021 from the nurse who stated the patient also desaturated, with oxygen (o2) levels decreasing from 99-100% to 40-60%. Symptoms improved with administration of 1 mg intravenous epinephrine, sodium bicarbonate (dose not provided) and 100% fio2. The patient was rechallenged with the device later that day, after being premedicated with intravenous diphenhydramine, methylprednisolone and famotidine, doses unspecified and experienced no further reaction.
 
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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 Key11242944
MDR Text Key232858603
Report Number3003464075-2021-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2022
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number00978004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/28/2021 Patient Sequence Number: 1
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