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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-172-C
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Apnea (1720); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Sweating (2444)
Event Date 02/05/2021
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. No device malfunction is associated with this report. 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. Biocompatibility has been established.
 
Event Description
A report was received on 05 feb 2021 from the nurse of a male patient, with a medical history including iga nephropathy, hypertension, gout and end stage renal disease, who stated the patient became unresponsive and diaphoretic approximately twenty minutes into his first hemodialysis treatment with the nxstage system on (b)(6) 2021. Symptoms resolved with return of the blood circuit via rinseback. Shortly after symptoms resolved (time not specified), the patient was rechallenged and within one minute became unresponsive with low blood pressure (104/62mmhg), diaphoresis and a decreased respiratory rate (nos). Emergency medical services (ems) were called and rinseback of the blood circuit was performed. Symptoms resolved prior to ems arrival and no medical intervention was required. Additional information was received on 10 feb 2021 from the nurse stating no dyspnea or apnea was associated with the decreased respiratory rate. The patient recovered without medical intervention and his physician prescribed a dialyzer from a different manufacturer for his ongoing hemodialysis treatments.
 
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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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11408107
MDR Text Key234893735
Report Number3003464075-2021-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K140526
Exemption Number5645646
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2022
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number00977022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2020
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: 03/03/2021 Patient Sequence Number: 1
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