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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 Output Problem (3005)
Patient Problems Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Muscle Weakness (1967)
Event Date 03/14/2022
Event Type  Injury  
Event Description
A report was received on 20 apr 2022 from the home therapy nurse (htn) of a (b)(6) male with a medical history including end stage renal disease, who stated the patient experienced blood loss via an unclamped heparin line during hemodialysis therapy on (b)(6) 2022. Additional information was received on 05 may 2022 from the home therapy manager (htm) stating the patient lost approximately 650ml of blood during therapy and presented to the emergency department (ed) with fatigue, headache and generalized weakness where they were admitted on (b)(6) 2022. Treatment in the ed included administration of saline (175ml) and ondansetron (dose and route unspecified). The patient remained hospitalized until (b)(6) 2022 when he was released in stable condition.
 
Manufacturer Narrative
The involved cartridge was not received for evaluation. A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release. There was no indication of a device malfunction from the available information. The cartridge instructions for use provides information and warnings associated with performing hemodialysis therapy. It warns the user to secure caps and close clamps prior to use to prevent air entry or blood loss.
 
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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 Key14317677
MDR Text Key291206803
Report Number3003464075-2022-00016
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
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 Number11177034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2021
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: 05/07/2022 Patient Sequence Number: 1
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