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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 RFP-401
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problems Fall (1848); Injury (2348)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative
The product met all quality criteria and manufacturing specifications prior to release and was not returned for evaluation.Nxstage medical considers this report closed.No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2018 from a nurse stating that a family member sustained a fall on (b)(6) 2018 when they slipped on dialysate fluid that spilled on the floor from a burst bag.The family member attended the emergency room for a possible biceps tear.
 
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product was released meeting all quality criteria and manufacturing specifications.
 
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Brand Name
NXSTAGE SYSTEM ONE
Type of Device
HIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
MDR Report Key7924435
MDR Text Key122297655
Report Number3003464075-2018-00040
Device Sequence Number1
Product Code KPO
Combination Product (y/n)Y
PMA/PMN Number
K053286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/01/2005,10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2020
Device Model NumberRFP-401
Device Catalogue NumberRFP-401
Device Lot NumberQ1803828
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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