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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 NX1000-5-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 04/04/2020
Event Type  Death  
Manufacturer Narrative
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. A search of the complaint database revealed no other serious events for the involved device. The device log file information was reviewed and verified the proper functionality of the device and sensors during the last two treatments performed on the patient. There is no information to indicate that a malfunction occurred. Udi: (b)(4).
 
Event Description
A report was received on 05 apr 2020 from a critical care nurse regarding a male critical care patient (age not specified), with significant comorbidities including five vessel coronary artery bypass graft surgery on (b)(6) 2020, emphysema, fatty liver, type ii diabetes and hypertension who coded and subsequently expired shortly after pausing therapy to adjust prescription details during continuous venovenous hemodialysis (cvvhd) on (b)(6) 2020. Additional information was received on 14 apr 2020 from the nurse stating the patient had an elevated potassium of 6. 6 meq/l at 18:40hrs on (b)(6) 2020 and had been receiving nxstage therapy for approximately 26 hours at the time of the event. No other treatment, medical intervention details or time and cause of death were 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 Key9977286
MDR Text Key188241640
Report Number3003464075-2020-00023
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 01/01/2005,04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-5-A
Device Catalogue NumberNX1000-5-A
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 Received04/05/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/20/2020 Patient Sequence Number: 1
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