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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 NX1000-5-A
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/13/2019
Event Type  Injury  
Manufacturer Narrative
The device was evaluated on site by a qualified biomedical engineer and was found to be functioning as designed and intended with no trouble found. 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. Udi: (b)(4).
 
Event Description
A report was received on 31 oct 2019 from a healthcare professional regarding a patient with unknown comorbidities who was in critical care unit for an unspecified medical condition, stating rinseback of the patient¿s blood following extracorporeal hemodialysis therapy could not be completed. The patient sustained a blood loss, amount not provided, and received a blood transfusion on (b)(6) 2019. Additional information was received on 19 nov 2019 from the biomedical engineer, who stated the device was evaluated and found to be functioning as designed and intended with no trouble found. No additional information or treatment details were provided.
 
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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 Key9355846
MDR Text Key167620887
Report Number3003464075-2019-00063
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/01/2005,11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-5-A
Device Catalogue NumberACUTE CYCLER 3RD EDITION, ROHS
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 Received10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/21/2019 Patient Sequence Number: 1
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