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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number SLE-3000M3095
Device Problem Fluid Leak (1250)
Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative
The device history record (dhr) was reviewed which confirmed there were no quality issues found during the manufacturing process or during inspection of this lot. A review of the database was conducted for the involved lot number with no additional cases found. The device was returned for investigation and evaluation. Testing confirmed the presence of a crack in the luer connector. The instructions for use warn that the device must only be used by trained and qualified personnel who must inspect the set prior to use, secure all connections to minimize leaks or accidental disconnections, and monitor all connections continually throughout treatment. It warns that only connectors known to be free of lubricious fluids may be attached to the luer connectors. (b)(4).
 
Event Description
A report was received on (b)(4) 2017, regarding a patient with unknown comorbidities who became hypotensive and lost consciousness during a standard hemodialysis treatment. The nurse stated an estimated 300 ml of blood leaked from the medication port while administering intradialytic parenteral nutrition. The patient was given intravenous normal saline and stabilized. She was admitted to hospital for observation only and was discharged on (b)(6) 2017.
 
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Brand NameMEDISYSTEMS CORPORATION (A NXSTAGE COMPANY)
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY)
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
9786874700
MDR Report Key7152664
MDR Text Key96005015
Report Number2919260-2017-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2018
Device Model NumberSLE-3000M3095
Device Catalogue NumberSLE-3000M3095
Device Lot Number71056002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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