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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-505
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiopulmonary Arrest (1765); Reaction (2414); Sweating (2444)
Event Date 11/04/2017
Event Type  Injury  
Manufacturer Narrative
The cartridge was not retained for investigation. The device history record was reviewed and no related defects were found during the manufacturing of this lot. Biocompatibility of the device has been established. Allergic or adverse reactions are known risks of hemodialysis. The nxstage one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and also includes warnings to observe the patient and monitor physical status for potential complications.
 
Event Description
A report was received on (b)(6) 2017 from a critical care nurse regarding a (b)(6)-old male who became symptomatic within minutes of starting continuous renal replacement therapy (crrt) on (b)(6) 2017. The patient became diaphoretic, flushed, felt unwell and subsequently coded. Resuscitation efforts including intramuscular epinephrine and intravenous benadryl were successfully performed with the patient stabilizing and regaining consciousness. The patient later dialyzed on a haemodialysis system from a different manufacturer without issues.
 
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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 Key7050051
MDR Text Key92719328
Report Number3003464075-2017-00052
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2019
Device Model NumberCAR-505
Device Catalogue NumberCAR-505
Device Lot Number70978010
Other Device ID Number+M535CAR5050/$$041970978010+
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2017 Patient Sequence Number: 1
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