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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 Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Chills (2191); Confusion/ Disorientation (2553); Lethargy (2560)
Event Date 10/28/2020
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. Allergic or adverse reactions are known risks of hemodialysis. 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. Biocompatibility of the device has been established.
 
Event Description
A report was received on 28 oct 2020 from the home therapy nurse (htn) of a (b)(6)- year old female patient with a medical history including end stage renal disease, and a prior hypersensitivity type reaction during a home hemodialysis session on an unspecified date, stating the patient experienced an allergic reaction during an incenter hemodialysis treatment on (b)(6) 2020. Additional information was received on 29 oct 2020 from the htn who stated that the patient received a prophylactic intravenous dose of diphenhydramine (nos) prior to their hemodialysis treatment on (b)(6) 2020, and experienced shortness of breath, chills, lethargy and disorientation. The patient was transported to the emergency department on (b)(6) 2020, and released on 15 oct 2020. Although requested, no further treatment information or details of the hospital visit were provided.
 
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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 Key10891427
MDR Text Key217919008
Report Number3003464075-2020-00077
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2022
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number00877051
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: 11/24/2020 Patient Sequence Number: 1
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