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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 CAR-172-C
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
The cartridge was discarded and was not available for evaluation. A device history record (dhr) review was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements. A review of the complaint database revealed no other reports of this issue for this lot number. The instructions for use states "make sure mated luer-connectors are secure but do not over-tighten, especially when connections are wet".
 
Event Description
A report was received on (b)(6) 2020 from the nurse of an adult patient within a skilled nursing facility for unspecified pathology, stating the cartridge luer broke within the patient¿s central venous catheter (cvc) while disconnecting following completion of a hemodialysis treatment on (b)(6) 2020. The patient¿s cvc required replacement.
 
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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 Key10430333
MDR Text Key204573092
Report Number3003464075-2020-00052
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2022
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number00577057
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 Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/20/2020 Patient Sequence Number: 1
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