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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 Improper or Incorrect Procedure or Method (2017); Connection Problem (2900)
Patient Problems Death (1802); Blood Loss (2597)
Event Date 10/29/2019
Event Type  Death  
Manufacturer Narrative
The involved device was not received for evaluation. 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. The nxstage system one user guide (supplement for solo home hemodialysis) states that all treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. A trained and qualified patient may dialyze alone, provided the patient and his or her physician agree that solo home hemodialysis is appropriate. Additional ancillary devices and training are required when performing solo home hemodialysis. The user guide warns that certain risks associated with hemodialysis treatment may increase when therapy is performed without a care partner. These risks may include, but are not limited to, blood loss leading to death during treatment. Udi #: (b)(4).
 
Event Description
A report was received on 27 nov 2019 from a home therapy nurse (htn), regarding the discontinuation of an (b)(6) year old male trained and approved for performing solo home hemodialysis treatments with the nxstage system. Additional information was received on 14 jan 2020 from the htn stating the patient had expired during hemodialysis therapy while connected to the device due to a use error. Per the htn, the patient disconnected the bloodline to adjust his access needles early in treatment and made erroneous connections when reconnecting to continue therapy, resulting in approximately 2l of blood loss into the saline bag. A person unfamiliar with hemodialysis and present at the time of the event noted the patient looked unwell and contacted emergency services who pronounced the patient deceased upon their arrival. Per the htn, there was no device malfunction and the reported event is related to a use error, unrelated to nxstage product and therapy.
 
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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 Key9667358
MDR Text Key177668598
Report Number3003464075-2020-00008
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 01/01/2005,02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberNXSTAGE SYSTEM ONE
Was Device Available for Evaluation? No
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 Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/04/2020 Patient Sequence Number: 1
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