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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 Disconnection (1171)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Loss of consciousness (2418); Blood Loss (2597)
Event Date 12/22/2020
Event Type  Death  
Manufacturer Narrative
The involved cycler was not received for evaluation. 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. Needle dislodgement is a recognized risk of hemodialysis therapy. The nxstage system one user guide warns that access sites must be taped per the dialysis facility procedures and checked when the patient changes position, must remain visible throughout treatment and that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly. Udi: (b)(4).
 
Event Description
A report was received on 24 dec 2020 from the home therapy nurse (htn) of a (b)(6) year old male with a bad heart condition including previous coronary artery bypass surgery (x5 grafts) and end stage renal disease, who stated the patient expired after experiencing blood loss (amount not provided) from dislodged needles on (b)(6) 2020. Additional information was received on 30 dec 2020 from the htn who stated the patient was approximately four hours into a six-hour treatment and the care partner was not present in the room, returning when the patient called for assistance. Per the nurse, the patient was in bed and dislodged the hemodialysis needles when turning over leading to an unspecified amount of blood loss, loss of consciousness and cardiopulmonary arrest. Emergency medical services were called and established return of spontaneous circulation followed by transport to hospital where two units of blood were given. While at the hospital the patient lost consciousness for a second time, was unable to be revived and subsequently expired on (b)(6) 2020, time 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 Key11179795
MDR Text Key227473022
Report Number3003464075-2021-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberCHRONIC HI-FLOW CYCLER, ROHS
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: 01/15/2021 Patient Sequence Number: 1
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