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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Pain (1994); Swelling (2091); Hypovolemia (2243); Blood Loss (2597); No Code Available (3191)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. There is no information to indicate that a malfunction occurred. The log file for the event was received and analyzed, confirming the treatment proceeded uneventfully and was terminated with automated rinseback. There was no indication of a device malfunction.
 
Event Description
A report was received on (b)(6) 2020 from a health care professional regarding a (b)(6)year old female with end stage renal disease who experienced fatigue, pallor and hypotension (77/57 mmhg) during a hemodialysis treatment on (b)(6) 2020. The nurse elected to terminate treatment and automated rinseback was performed successfully. On removing the cartridge, the nurse noted approximately 200ml of blood loss, the source of which could not be determined. The patient attended the emergency room later that day with pain and swelling in her arteriovenous fistula (avf). Additional information was received on 01 sep 2020 from a health care professional who stated the patient was hypovolemic and their hemoglobin decreased from 8. 7 g/dl to 5. 6 g/dl. The patient was observed overnight and released with no medical intervention reported.
 
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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 Key10501222
MDR Text Key205888994
Report Number3003464075-2020-00059
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2021
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number91277010
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 Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
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