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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 Erythema (1840); Itching Sensation (1943)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
A cartridge lot number was not provided. Without a lot number, a review of the device history record (dhr) is unable to be performed. All product is released having met all manufacturing specifications and quality requirements. There is no information to indicate that a malfunction occurred. The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions. Monitoring of the patient should be performed regularly to ensure an appropriate response to therapy. Biocompatability has been established.
 
Event Description
A report was received on 26 aug 2020 from the home therapy nurse (htn) of a (b)(6) male patient with a medical history of end stage renal disease, stating the patient developed erythema and became itchy approximately 5 minutes into their second hemodialysis treatment with the nxstage device on (b)(6) 2020. Treatment was terminated with administration of intravenous (iv) hydrocortisone (100mg), oral antihistamine (nos), and oral paracetamol. Additional information was received on 28 aug 2020 from the htn confirming symptoms resolved after 20 minutes and the patient recovered without sequelae, continuing to treat with the nxstage system and using a dialyzer from a different manufacturer.
 
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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 Key10556934
MDR Text Key207698312
Report Number3003464075-2020-00061
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/18/2020 Patient Sequence Number: 1
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