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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 Fluid Leak (1250)
Patient Problems Dizziness (2194); Blood Loss (2597)
Event Date 01/03/2021
Event Type  Injury  
Manufacturer Narrative
The cartridge was discarded by the patient and was not available for evaluation. A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements. The nxstage system one user guide (ug) states a trained and qualified person must respond promptly and appropriately to all alarms and harmful conditions during treatment. The ug supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient. The ug also warns the user to test the fluid leak sensor alarm prior to treatment.
 
Event Description
A report was received on 29 jan 2021 from the home therapy nurse (htn) of a (b)(6) year old male with multiple comorbidities including end stage renal disease and anemia of chronic kidney disease, approved for performing solo home hemodialysis therapy, stating the patient experienced dizziness following an unspecified amount of blood loss during a home hemodialysis session on (b)(6) 2021. Per the htn the patient stated the blood loss was ¿coming from the filter¿ and the patient attended hospital to receive a blood transfusion. Additional information was received on 01 feb 2021 from the htn, who stated that the patient was transfused in the emergency department with one unit of packed red blood cells and released to home same day, (b)(6) 2021. No further details of the blood loss were provided, the patient recovered without sequelae and continues to treat using the nxstage system.
 
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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 Key11275886
MDR Text Key233501825
Report Number3003464075-2021-00005
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 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2022
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number00777046
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: 02/03/2021 Patient Sequence Number: 1
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