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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 NX1000-16-A
Device Problem Obstruction of Flow (2423)
Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)
Event Date 06/04/2020
Event Type  Injury  
Manufacturer Narrative
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. A review of the complaint database revealed no other events of this nature for the reported device serial number. There was no indication of a device malfunction from the available information. Udi: (b)(4).
 
Event Description
A report was received on 04 jun 2020 from the caregiver of a (b)(6) year old female patient with multiple comorbidities including end stage renal disease with hemodialysis treatments performed using a central venous catheter, stating the patient visualized air in her blood lines (amount not available) followed by chest discomfort (nos) and shortness of breath at an unspecified time shortly after returning her blood to complete a standard home hemodialysis session on (b)(6) 2020. Additional information was received on 16 jun 2020 from the home therapy nurse (htn) indicating that the patient's symptoms improved at home within an hour and without medical intervention on (b)(6) 2020. The patient elected to go to the emergency department for assessment and was admitted for observation, serial troponins and diagnostic imaging. All testing returned unremarkable results. The attending physician indicated the event was not clinically significant and the patient was discharged without sequelae the following day, (b)(6) 2020. Per the htn, the patient continues to perform hemodialysis treatments with the nxstage system one.
 
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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 Key10191781
MDR Text Key197808075
Report Number3003464075-2020-00033
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-16-A
Device Catalogue NumberCYCLER VERSIHD, NO NIBP MODULE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received06/04/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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