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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-170-C
Device Problem Insufficient Information (3190)
Patient Problems Dyspnea (1816); Reaction (2414); No Code Available (3191)
Event Date 07/12/2017
Event Type  Injury  
Manufacturer Narrative
The cartridge was not retained for investigation. The device history record (dhr) for the cartridge lot number provided was reviewed and supports that no related defects were found during the manufacturing of this lot. All available information supports that the product was functioning as designed and there was no malfunction. The user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on july 18, 2017 from a home therapy nurse regarding a (b)(6) year old male patient. It was reported that approximately 5-10 minutes into a standard hemodialysis treatment on (b)(6) 2017 the patient experienced difficulty breathing and became unresponsive. Symptoms persisted for approximately 15 minutes and the patient was transferred to hospital without medical intervention. He was admitted and received hemodialysis with a dialyzer from a different manufacturer. No other treatment was required. He was discharged on (b)(6) 2017 with a discharge diagnosis of ''type a dialyzer reaction''. The patient continues to treat without event using the nxstage system and a dialyzer from the third party manufacturer.
 
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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 Key6755094
MDR Text Key81465515
Report Number3003464075-2017-00034
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2019
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number70577042
Other Device ID Number+M535CAR170C0/$$0119705770425
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 Received07/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/31/2017 Patient Sequence Number: 1
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