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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 Problem Use of Device Problem (1670)
Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914)
Event Date 08/21/2017
Event Type  Injury  
Manufacturer Narrative
There is no information to indicate that a device malfunction occurred. The available information supports that the device alarmed appropriately and performed as designed and intended. The nxstage system one user guide provides information for troubleshooting alarms and performing rinseback in the event alarms cannot be resolved. The device has not been received for evaluation and no serial number was provided, therefore a device history record (dhr) review could not be performed. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2017 regarding a (b)(6) female who felt unwell while troubleshooting alarms during a standard home hemodialysis treatment and went to the hospital for evaluation. Additional information received from the home therapy nurse on august 28, 2017 revealed that the patient had experienced a hypotensive episode and stroke-like symptoms and she had remained in hospital from (b)(6) 2017. The htn stated that the patient had experienced 4 - 5 blood loss events (approx. 190 ml each time) during the previous week due to use issues during troubleshooting which exacerbated her existing anemia and hypotension. Her epogen dosage was increased and hemodialysis treatment was performed while in hospital. No other medical intervention was required and she was discharged in stable condition on (b)(6) 2017.
 
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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
9786874700
MDR Report Key6862579
MDR Text Key86082755
Report Number3003464075-2017-00043
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Patient
Type of Report Initial
Report Date 09/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/13/2017 Patient Sequence Number: 1
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