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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 NX1000-1
Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)
Patient Problem Anemia (1706)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
All product must meet quality requirements and manufacturing specifications prior to release. The nxstage system one user guide states a trained and qualified person must respond promptly and appropriately to all alarms and harmful conditions during treatment. The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient. There is no information to indicate that a malfunction occurred.
 
Event Description
A report was received on 27 sep 2020 from the home therapy nurse (htn) of a (b)(6) year old female patient with a medical history of anemia, end stage renal disease and approved for performing solo home hemodialysis therapy, stating the patient was unable to resolve a system generated alarm and elected to discard a blood circuit during a solo home hemodialysis treatment on (b)(6) 2020. Additional information was received on 29 sep 2020 from the htn who stated the patient was admitted to hospital with a diagnosis of "severe anemia" on (b)(6) 2020. Although requested, no information regarding the course of hospitalization was provided and the patient was discharged on (b)(6) 2020. Per the htn, the patient 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 Key10719051
MDR Text Key212548282
Report Number3003464075-2020-00071
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E W/ SERVICE COMPUTER
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: 10/22/2020 Patient Sequence Number: 1
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