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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 NX1000-16-A
Device Problem Insufficient Information (3190)
Patient Problems Encephalopathy (1833); Ischemia (1942); Muscle Weakness (1967); Loss of consciousness (2418)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
The device was received for evaluation and successfully passed all testing, confirming proper functionality of the device and sensors. Available log files were retrieved and analyzed which showed device performance was without incident and was unremarkable. 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. All information supports the device was functioning as designed and intended with no malfunction. The system one user guide includes instruction to the user to ¿not attempt manual rinseback if the blood circuit is clotted or hemolyzed, or if you see air within the blood circuit or in the patient blood lines, or if otherwise directed by the center. ¿ the user guide also includes a warning to the user ¿when performing manual rinseback, the nxstage system one cycler door is open, which deactivates all safety systems. The operator must visually monitor for air in the patient blood lines, to prevent an infusion of air, which may lead to an embolism. ¿ udi: (b)(4).
 
Event Description
A report was received on 14 apr 2021 from the home therapy nurse (htn) regarding a (b)(6) year old male patient with a complex medical history including hypertension and end stage renal disease, who stated the patient lost consciousness during a standard home hemodialysis treatment on (b)(6) 2021 and was transported to hospital. Additional information was received 16 - 23 apr 2021 from the htn who stated the patient lost consciousness after troubleshooting arterial air alarms and electing to have his blood rinsed back manually. The patient presented via ems to hospital with altered mental status, moaning and unresponsive, and was admitted to the intensive care unit (icu). A ct angiogram showed an area of possible ischemia (noted as small to moderate, size not specified) in the right posterior temporal lobe possibly due to an air embolism with the resulting encephalopathy likely accounting for the change in mental status. Per the htn the patient stabilized, and was released from the icu with left sided weakness. The patient was discharged from hospital in stable condition on (b)(6) 2021.
 
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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 Key11797793
MDR Text Key257151189
Report Number3003464075-2021-00021
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-16-A
Device Catalogue NumberCYCLER VERSIHD 1.0, NO NIBP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
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