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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 CAR-125-B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Asthma (1726); High Blood Pressure/ Hypertension (1908); Seizures (2063); Thrombosis (2100)
Event Date 10/07/2019
Event Type  Injury  
Manufacturer Narrative
The cartridge was received for evaluation and passed all testing with no trouble found. The involved dialyzer is from a different manufacturer and was not evaluated by nxstage. The device history record for the product was reviewed which confirmed the cartridge was released meeting all quality and manufacturing requirements. Biocompatibility has been established.
 
Event Description
A report was received on 8 oct 2019 from the home therapy nurse (htn), regarding an (b)(6) male with multiple comorbidities including asthma, inferior vena cava thrombosis, clotting disorder, anemia, hypertension, seizures, polycystic kidney and transplant failure who had pink-tinged effluent that tested negative for blood during standard home hemodialysis therapy on (b)(6) 2019. Per the htn treatment was terminated and the patient was taken to hospital by the caregiver for precautionary observation. Additional information was received 08 oct 2019 - 30 oct 2019 from the htn which revealed the patient was admitted to hospital from (b)(6) 2019 for blood tests and cultures (nos) which were unremarkable. The patient did not experience symptoms and received dialysis while hospitalized with no additional events reported.
 
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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 Key9268126
MDR Text Key165946613
Report Number3003464075-2019-00058
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date01/20/2021
Device Model NumberCAR-125-B
Device Catalogue NumberCAR-125-B
Device Lot Number90277048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
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 Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/01/2019 Patient Sequence Number: 1
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