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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-170-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urticaria (2278)
Event Date 05/20/2020
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 instructions for use warn that the device must be used under the prescription of a physician. 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 03 jun 2020 from the home therapy nurse (htn) regarding a (b)(6) year old male patient with multiple comorbidities including end stage renal disease, stating the patient experienced hives on his arms and legs, approximately forty-five minutes into his first hemodialysis treatment using the nxstage system one on (b)(6) 2020. Additional information was received on 04 jun 2020 from the htn who stated patient's symptoms onset almost immediately upon starting treatment. At an unspecified time iv benadryl 25mg was administered and treatment was terminated. Symptoms improved within 30 minutes of the iv benadryl, and the patient continues to perform therapy without event using the nxstage system one and treating with benadryl 25mg orally prior to each hemodialysis session.
 
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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 Key10186274
MDR Text Key198345639
Report Number3003464075-2020-00031
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
Type of Report Initial
Report Date 01/01/2005,06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2020
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number81277010
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 Received06/03/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/23/2020 Patient Sequence Number: 1
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