• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-170-C
Device Problem Fluid/Blood Leak (1250)
Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194)
Event Date 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
The involved device was not received for evaluation.A device history record (dhr) review was conducted which revealed the product was released for distribution having met quality and manufacturing specifications and requirements.Initial review of the log file associated with the case has not identified a device malfunction.Review of the database for the involved lot number found no other reports of this nature associated with the device.User-facing documentation for the product provides information on the risks associated with dialysis therapy and suggested actions, instructions, cautions and warnings to enable patients to treat safely and effectively.It states that all treatments with the device must be administered under the responsibility of a physician and must be observed by a trained and qualified person.The trained and qualified person is warned to respond appropriately to all alarms and harmful conditions during treatment.
 
Event Description
A report was received on 24 mar 2022 from a 52 year old female patient with a medical history of end stage renal disease, stating she felt lightheaded when an unspecified amount of blood leaked from the device during a hemodialysis treatment on (b)(6) 2022.Additional information was received on 24 mar 2022 from the home therapy nurse (htn), who stated treatment was terminated, 911 was called and the patient was evaluated by emergency medical system (ems).The patient recovered without sequelae and no medical intervention was required.
 
Manufacturer Narrative
No product was received for evaluation and a malfunction was not confirmed.A review of the device history record confirmed the device met all quality criteria and manufacturing specifications prior upon release.A search of the complaint database for the involved lot number found no additional reports of blood leaks during treatment.The instructions for use includes information to reduce the risk of blood leaks and warns users that all treatments must be observed by a trained and qualified person.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NXSTAGE SYSTEM ONE
Type of Device
HIGH 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
MDR Report Key14163486
MDR Text Key298955338
Report Number3003464075-2022-00012
Device Sequence Number1
Product Code KDI
UDI-Device IdentifierM535CAR170C0
UDI-Public+M535CAR170C0/$$0723201770775
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/01/2023
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number20177077
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/24/2022
Initial Date FDA Received04/20/2022
Supplement Dates Manufacturer Received03/24/2022
Supplement Dates FDA Received05/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NX1373: NXSTAGE SYSTEM ONE FLUID DETECTION KIT.
Patient Outcome(s) Other;
Patient Age52 YR
Patient SexFemale
Patient Weight104 KG
-
-