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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 NX1000-3-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of consciousness (2418); Loss Of Pulse (2562)
Event Date 03/26/2020
Event Type  Injury  
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. There is no information to indicate that a malfunction occurred. (b)(4).
 
Event Description
A report was received on (b)(6) 2020 from the home therapy nurse (htn) regarding a (b)(6) female with a pacemaker and history of cardiac disease, who was treating without a caregiver present and was found unresponsive and pulseless at an unspecified time during a home hemodialysis treatment on (b)(6) 2020. Additional information was received (b)(6) 2020 from the home therapy nurse (htn) who stated emergency services were contacted, resuscitative measures were performed with return of spontaneous circulation and the patient was transported to hospital. Hospitalization included testing for covid-19 (negative) and intubation for approximately a week. After extubation, the patient was conscious, alert and oriented and remained in hospital as of (b)(6) 2020.
 
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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 Key9922246
MDR Text Key186430122
Report Number3003464075-2020-00022
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K122051
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 01/01/2005,04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberNX1000-3-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 Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/03/2020 Patient Sequence Number: 1
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