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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 Problems Hemorrhage/Bleeding (1888); Test Result (2695)
Event Date 04/13/2020
Event Type  Injury  
Manufacturer Narrative
All devices must meet quality requirements and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage user guide and instructions for use include platelet decrease as a potential risk associated with dialysis therapy and also include warnings to monitor for potential platelet decrease. Biocompatability has been established.
 
Event Description
A report was received on 14 jul 2020 from a physician stating that a (b)(6) male patient with multiple comorbidities including ventilator dependence, persistent vegetative state, end stage renal disease and a history of gastrointestinal hemorrhage, had a decrease in platelet count and a gastrointestinal bleed on (b)(6) 2020. Additional information received on 28 jul 2020 from the healthcare professional indicated platelet levels on (b)(6) 2020 were 233×10^3/ul and on (b)(6) 2020 were 192×10^3/ul. Both values were within the medically defined normal range 150×10^3/ul to 450×10^3/ul. The patient had (b)(6) on (b)(6) 2020 and was admitted to hospital for a blood transfusion (nos). Evaluation included a ct scan of upper and lower gastrointestinal tract on (b)(6) 2020 with inconclusive results. 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 Key10387241
MDR Text Key207118901
Report Number3003464075-2020-00045
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 foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
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? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/10/2020 Patient Sequence Number: 1
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