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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Swelling (2091)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. The instructions for use warn that the device must be used under the prescription of a physician. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions. Monitoring of the patient should be performed regularly to ensure an appropriate response to therapy. Biocompatability has been established.
 
Event Description
A report was received on (b)(6) 2020 from the home therapy nurse (htn) of (b)(6), a (b)(6)year old female patient with multiple comorbidities, a previous documented anaphylactic reaction to hydralazine and end stage renal disease, stating the patient experienced facial swelling, throat constriction with difficulty swallowing and shortness of breath 21 minutes into their first hemodialysis session on (b)(6) 2020. Treatment was terminated 34 minutes after initiation, emergency medical services were called, and the patient was transferred to the emergency department. Additional information was received on 31 aug 2020 from the htn confirming symptoms resolved spontaneously and the patient was released from the emergency department with a diagnosis of angioedema later the same day, (b)(6) 2020.
 
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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 Key10549884
MDR Text Key207507862
Report Number3003464075-2020-00060
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
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 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2022
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number00677023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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