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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 NX1000-3
Device Problem Insufficient Information (3190)
Patient Problems Malaise (2359); Chest Tightness/Pressure (2463); Blood Loss (2597)
Event Date 10/01/2020
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. The nxstage system one user guide warns that a trained and qualified person must observe all treatments so that alarms and harmful conditions can be responded to promptly. There is no information to indicate that a malfunction occurred. (b)(4).
 
Event Description
A report was received on 02 oct 2020 from a (b)(6) year old male patient with end stage renal disease who had recently felt unwell (nos) and who stated he observed a "large pool of blood" underneath his chair at an unspecified time during a home hemodialysis treatment on (b)(6) 2020. Following treatment, the patient went to hospital on (b)(6) 2020. Additional information was received on 08 oct 2020 from the home therapy nurse (htn) who stated approximately 100-200 ml of blood was found dried on the floor on (b)(6) 2020 and the patient reported to the emergency room with chest tightness. The patient was observed, lab values returned a hemoglobin of 7. 7 g/dl and no medical intervention was provided. The patient was released same day, returning the following day to receive one unit of packed red blood cells. Following the event, the patient has recovered without sequelae and has resumed treatment with nxstage.
 
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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 Key10697368
MDR Text Key211894976
Report Number3003464075-2020-00068
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
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 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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: 10/19/2020 Patient Sequence Number: 1
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