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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
A cartridge lot number was not provided. Without a lot number, a review of the device history record (dhr) is unable to be performed. All product is released having met all manufacturing specifications and quality requirements. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. Biocompatability has been established.
 
Event Description
A report was received on 28 jul 2020 from a healthcare professional regarding an (b)(6) year old male with a history of hematuria, current use of warfarin and multiple comorbidities including end stage renal disease, stating the patient performed hemodialysis treatments with the device and experienced bleeding (nos) on an unspecified date. The patient changed to a dialyzer from a different manufacturer and recovered without sequelae, continuing to perform hemodialysis treatments using the nxstage system one.
 
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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 Key10430782
MDR Text Key203655849
Report Number3003464075-2020-00053
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeSA
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 01/01/2005,08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-172
Device Catalogue NumberCAR-172
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 Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/20/2020 Patient Sequence Number: 1
Treatment
WARFARIN, DOSE AND FREQUENCY NOT PROVIDED
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