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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 Detachment of Device or Device Component (2907)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Event Date 07/22/2019
Event Type  Injury  
Manufacturer Narrative
The cartridge was discarded by the user and was not available for evaluation. A lot number for the cartridge was not provided. Without a lot number, a review of the device history record (dhr) could not be performed. Log files from the hemodialysis cycler were provided and analyzed for the event which confirmed the system was functioning as designed with alarms and cautions generated according to specifications. The available information does not indicate a device malfunction occurred. The instructions for use (ifu) warn that the cartridge has multiple connection points, and failure to make the proper connections can cause compromised treatment, blood loss, injury or death. The ifu outlines methods to reduce the risk of fluid or blood leaks, or accidental disconnections. A trained and qualified observer must check the system for blood and fluid leaks during treatment, pay close attention to the blood line and access connections, and keep vascular access sites and all cartridge connections visible throughout the treatment.
 
Event Description
A report was received on (b)(6) 2019 from a biomedical engineer regarding a critical care patient with history of acute kidney injury, stating the patient lost an unspecified amount of blood when the venous line disconnected from the patient's central venous catheter device during continuous renal replacement therapy (crrt) on (b)(6) 2019. The patient¿s blood pressure decreased (values not provided) and was stabilized with increased vasopressors (nos) and discontinuation of crrt. Additional information was received on 29 jul 2019 from the nurse manager stating a transfusion of 2 units of packed red blood cells was required and the patient recovered without sequelae.
 
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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 Key8911657
MDR Text Key155027115
Report Number3003464075-2019-00041
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 Biomedical Engineer
Type of Report Initial
Report Date 01/01/2005,08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-505
Device Catalogue NumberCAR-505
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
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/20/2019 Patient Sequence Number: 1
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