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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE WITH LOCKSITES HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE WITH LOCKSITES HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-172-C
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 04/11/2022
Event Type  Injury  
Event Description
A report was received on (b)(6) 2022 from the care partner of a (b)(6) female patient stating the patient felt sick, weak, and unwell approximately one hour into a home hemodialysis treatment on (b)(6) 2022. Upon terminating treatment, an unspecified amount of blood was noted on the floor and surrounding the device. Emergency medical services were called and the patient was transported to hospital where they were admitted. Additional information provided on (b)(6) 2022 from the home therapy nurse (htn) who stated the patient clamped the heparin line incorrectly. Details of the hospital admission were not provided. Per the htn, the patient is now ¿doing well¿ and has resumed therapy with the nxstage system.
 
Manufacturer Narrative
The involved device was not received for evaluation and a lot number was not provided. All devices must meet quality requirements and manufacturing specifications prior to release. The instructions for use warns the user to secure caps and close clamps prior to use to prevent air entry or blood loss.
 
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Brand NameNXSTAGE CARTRIDGE WITH LOCKSITES
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
MDR Report Key14289214
MDR Text Key290920109
Report Number3003464075-2022-00015
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2022 Patient Sequence Number: 1
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