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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-505
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 11/16/2019
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.In the critical care setting, the patient¿s treatments are prepared and continuously monitored by trained healthcare professionals.The instructions for use includes the following warnings: secure caps and close clamps after priming and after each use to prevent blood loss or air entering the patient blood lines.Before starting treatment, make sure all manual connections are secure and fluid-tight, but not over-tight.A trained and qualified observer must check the system for blood and fluid leaks during treatment and pay close attention to the blood line and access connections.
 
Event Description
A report was received on 18 nov 2019 from the nurse of a (b)(6) male being treated in the critical care unit for a gastrointestinal bleed and low hemoglobin (7.3g/dl), who experienced hypotension and lost approximately 75ml blood via a loose cartridge connection during a hemodialysis treatment on (b)(6) 2019.Treatment was terminated without rinseback of the dialysis circuit, with blood loss totaling approximately 250ml.Additional information was received on 21 nov 2019 from the nurse stating the patient became unresponsive, required intubation and was transfused with 2 units of blood.Hb improved to 9.2g/dl post transfusion, the patient recovered without sequelae and resumed therapy with the nxstage system.
 
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Brand Name
NXSTAGE SYSTEM ONE
Type of Device
HIGH 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 Key9385674
MDR Text Key168810447
Report Number3003464075-2019-00071
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/01/2005,11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Model NumberCAR-505
Device Catalogue NumberCAR-505
Device Lot Number90778012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 11/18/2019
Initial Date FDA Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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