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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 Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Event Date 11/23/2020
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. The patient¿s blood pressure, vital signs, general well-being, and physical status should be monitored closely throughout the treatment. Biocompatability has been established.
 
Event Description
A report was received on 23 nov 2020 from the nurse of a (b)(6) year old female with a medical history including diabetes, hypertension, hyperlipidemia and end stage renal disease, who stated the patient experienced an allergic reaction during their first hemodialysis treatment with the device on (b)(6) 2020. Additional information was received on 01 dec 2020 from the nurse who stated approximately thirty minutes into treatment on (b)(6) 2020 the patient experienced swelling of her eyes and face. 50mg of diphenhydramine was administered intravenously, oxygen was applied via nasal canula and the patient was transported to the emergency room. Following the event the patient recovered without sequelae and has changed to an unspecified device from a different 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
9784505276
MDR Report Key10985337
MDR Text Key220762832
Report Number3003464075-2020-00079
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2021
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number91177051
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: 12/10/2020 Patient Sequence Number: 1
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