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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 NX1000-16-A
Device Problems Entrapment of Device (1212); Fluid Leak (1250); Device Dislodged or Dislocated (2923)
Patient Problems Death (1802); Blood Loss (2597)
Event Date 10/27/2020
Event Type  Death  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release. A review of the complaint database revealed no other events of this nature for the reported device serial number. The device was requested for return. The clinic confirmed the device is being held as part of an open investigation and is not available for return. There was no indication of a device malfunction from the available information. (b)(4).
 
Event Description
A report was received on 28 oct 2020 from the (b)(6) of a (b)(6) year old male patient with a medical history of end stage renal disease approved for solo use stating the patient expired during a hemodialysis treatment on (b)(6) 2020. Additional information was received on 03 nov 2020 from the (b)(6) who stated that the heparin line was not clamped and the patient experienced a blood leak during treatment. At an unspecified time, the patient transferred into his wheelchair and began to move toward the bathroom. Per the reporter, the patient¿s access line was caught in the left wheel of the chair causing both needles to dislodge from his arm. Per the htn the cause of death has not been determined.
 
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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 Key10884771
MDR Text Key217674724
Report Number3003464075-2020-00075
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-16-A
Device Catalogue NumberCYCLER VERSIHD 1.0 NO NIBP MOD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/23/2020 Patient Sequence Number: 1
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