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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 Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problem Blood Loss (2597)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
The cartridge was not available for evaluation. A review of the device history record (dhr) was performed and revealed no related defects were found during the manufacturing and the lot was released for distribution having met all product design requirements. There is no information to indicate that a malfunction occurred. The reported event is consistent with a use issue and not a product malfunction. The instructions for use (ifu) warns the operator to secure caps and close clamps after priming and after each use to prevent blood loss. Biocompatibility has been established. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2018 from a physician regarding a (b)(6) female patient with a history of heart failure (nos) who was found unconsciousness (time unconscious and time into treatment before losing consciousness unknown) during a standard home hemodialysis treatment on (b)(6) 2018. Blood loss of approximately 250-500 ml was found leaking from the unclamped heparin line. The patient was admitted to the intensive care unit (icu) and hospitalized from (b)(6) 2018 with a hemoglobin of 6. 7 g/dl and hematocrit of 0. 209. Treatment included volume support (nos) without blood transfusion or use of vasopressors. The physician stated the reported event was due to a use issue, as the patient did not clamp the heparin line, or secure the caps. The patient recovered without sequelae and continues to treat using nxstage products and therapy at a dialysis facility.
 
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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
9786874700
MDR Report Key7876307
MDR Text Key120249509
Report Number3003464075-2018-00037
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 Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,09/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2019
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number80177012
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 Received09/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/14/2018 Patient Sequence Number: 1
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