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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Test Result (2695)
Event Date 11/25/2020
Event Type  Injury  
Manufacturer Narrative
There is no information to indicate that a malfunction occurred. The product meets all quality criteria and manufacturing specifications prior to release. Adverse reactions are known risks of hemodialysis, and the nxstage user guide and instructions for use include platelet decrease as a potential risk associated with dialysis therapy. The documents include warnings to monitor for potential adverse reactions. Biocompatability has been established.
 
Event Description
A report was received on 25 nov 2020 from a healthcare professional regarding a (b)(6) year old male patient with end stage renal disease, who experienced a platelet decrease while performing hemodialysis treatments with the nxstage system. Additional information was received on 04 dec 2020 from a healthcare professional, stating the patient began hemodialysis therapy with the nxstage system on (b)(6) 2020 and experienced an increased bleeding tendency and prolonged clotting time. No medical intervention has been required.
 
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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 Key11015316
MDR Text Key221746421
Report Number3003464075-2020-00080
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeSW
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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