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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 Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411)
Event Date 10/21/2021
Event Type  Injury  
Event Description
A report was received on 22 oct 2021 from the home therapy nurse (htn) of a (b)(6)-year-old female patient with a medical history including multiple comorbidities and end stage renal disease, who stated that the patient experienced decreased blood pressure (nos) during a hemodialysis treatment on (b)(6) 2021. Per the htn, the patient attempted a saline bolus and noted a blood leak from ¿a small pinhole leak in the art line¿. Emergency medical services (ems) were contacted and transported patient to hospital for evaluation. Additional information was received on 26 oct 2021 from the htn stating that the patient was admitted to hospital from (b)(6) 2021 for acute blood loss anemia and syncope. While admitted, patient received 2 units of red blood cells. Per the htn, the patient has recovered without sequelae and continues to treat with the nxstage system.
 
Manufacturer Narrative
The product was received for evaluation and successfully passed testing, no leaks or occlusions were observed and all luers and connectors were intact with no compromised integrity found. 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. Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable. The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.
 
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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
MDR Report Key12805635
MDR Text Key280746899
Report Number3003464075-2021-00066
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 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number10777046
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2021
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: 11/12/2021 Patient Sequence Number: 1
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