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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Congestive Heart Failure (1783); Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
There was no indication of a device malfunction. No lot number was provided so review of the device history record could not be conducted. All devices must meet quality requirements and manufacturing specifications prior to release. Bio-compatibility has been established. The instructions for use warns that the device must be used under the prescription of a physician. The user guide includes a decrease in platelet count as a potential risk associated with dialysis therapy and states monitoring of the patient should be performed regularly to ensure an appropriate response to therapy.
 
Event Description
A report was received on (b)(6) 2020 from the nurse regarding a (b)(6) year old male patient with a complex medical history including decompensated cardiogenic / septic shock, acute kidney injury and congestive heart failure who experienced a platelet decrease during continuous renal replacement therapy (crrt) with the nxstage system. Additional information was received on 08 jun 2020 from the nurse who stated crrt was performed using the nxstage device from (b)(6) 2020 with platelets ranging from 85,000 ¿ 162,000/mcl during this time. Per the nurse, the patient was given plasma, platelets and packed red blood cells during treatment, amounts, dates and times not provided.
 
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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 Key10190995
MDR Text Key196404226
Report Number3003464075-2020-00032
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
Type of Report Initial
Report Date 01/01/2005,06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
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 Received06/04/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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