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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Vomiting (2144)
Event Date 12/22/2017
Event Type  Injury  
Manufacturer Narrative
The cycler and express fluid warmer were returned for evaluation and there was no malfunction. Both devices passed all testing and were found to perform as designed and intended. Log files were received and analyzed, and confirmed that the system performed as designed during treatment, with no indication of a causal relationship to the patient adverse event. A device history record (dhr) review for the cycler was conducted and revealed the product was released having met all design and acceptance requirements prior to release. A cartridge dhr review was performed and showed that the lot was released having met all quality and manufacturing specifications and requirements. Biocompatibility of the device has been established. An express fluid warmer dhr review was conducted and showed no defects during the manufacturing of the device. Although the available information supports that nxstage equipment and therapy was functioning as designed, a relationship between the device and the reported symptoms cannot be excluded. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 22 dec 2017 regarding a (b)(6) female patient who developed symptoms of vomiting, abdominal pain and hypertension approximately two hours into a standard in-center hemodialysis treatment. Therapy was discontinued and the patient was admitted to the hospital on (b)(6) 2017 with suspected hemolysis. Treatment included administration of paracetamol and oramorph for pain relief, and 1650 units of intravenous dalteparin prior to discharge on (b)(6) 2017. Although requested no discharge diagnosis was provided. The patient was changed to a dialyzer from a different manufacturer and continues to treat 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
9786874700
MDR Report Key7193556
MDR Text Key97328786
Report Number3003464075-2018-00002
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2013
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: 01/16/2018 Patient Sequence Number: 1
Treatment
CORDIAX FX60
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