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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 Connection Problem (2900)
Patient Problems Death (1802); Exsanguination (1841); Low Blood Pressure/ Hypotension (1914)
Event Date 07/19/2018
Event Type  Death  
Manufacturer Narrative
The involved cycler was received for evaluation and found to be functioning as designed and intended with no unexpected device behavior. A review of the device history record (dhr) was conducted and confirmed the product was released meeting all quality criteria and manufacturing specifications. The supporting evidence provided by review of the log file confirms there was no malfunction or product deficiency. All treatments with the nxstage system one must be performed by a trained and qualified person under the responsibility of a physician. The nxstage system one user guide warns that failure to make the proper connections may cause compromised treatment, blood loss, injury or death. (b)(4). Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(4) 2018 from a home training nurse (htn) regarding a (b)(6)year old female patient with a medical history of chronic cocaine use, hypertensive cardiovascular disease, nasal oxygen use (nos), deteriorating health (nos), buttonhole access issues, malaise and weakness who became symptomatic during standard hemodialysis therapy on (b)(6) 2018. During the first 10-15 minutes of treatment the patient became hypotensive, incoherent and restless, causing her needles and nasal oxygen to become dislodged. Treatment could not be resumed due to the dislodged needle and was terminated using the emergency rinseback procedure. During rinseback the bloodlines were incorrectly connected by the caregiver causing approximately 550ml of blood loss into the saline bag. The patient experienced a decrease in systolic blood pressure (80mmhg) and respiratory distress. Cardiopulmonary resuscitation (cpr) was initiated and 911 was called. Despite resuscitation efforts the patient expired. Per the htn, the patient's death was related to their comorbidities and unrelated to nxstage products or therapy. Follow up information was received on 12 oct 2018 from the chief medical examiner stating the cause of death was related to acute blood loss due to incorrect vascular connection during dialysis with contributing factors of hypertensive cardiovascular disease and chronic cocaine use.
 
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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 Key8033692
MDR Text Key125977277
Report Number3003464075-2018-00057
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 01/01/2005,11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2018
Is the Reporter a Health Professional? Yes
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 Received10/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2013
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: 11/02/2018 Patient Sequence Number: 1
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