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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-171-C
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling (2091)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release. Biocompatibility has been established. There is no information to indicate that a malfunction occurred. The user guide and instructions for use include allergic reaction as a potential risk associated with dialysis treatments and also include warnings to monitor for potential allergic reactions. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2018 from a nurse regarding a (b)(6) female, with medical history significant for a recent reaction during their previous short daily hemodialysis treatment, who became symptomatic during rechallenge on (b)(6) 2018. Within 2 minutes of treatment commencing, the patient experienced itchiness of the head, back and arms, and facial flushing. 10mg iv chlorphenamine was administered. The patient then experienced generalized itching and lip swelling. 200mg hydrocortisone and 0. 5mg epinephrine were given intravenously and no further symptoms were reported. The patient was observed in the facility for 6 hours and recovered without sequelae. The following day dialysis therapy was performed using a conventional hemodialysis device from another manufacturer without issue.
 
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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 Key8050862
MDR Text Key126545226
Report Number3003464075-2018-00058
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 01/01/2005,11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2020
Device Model NumberCAR-171-C
Device Catalogue NumberCAR-171-C
Device Lot Number80677035
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 Received10/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/08/2018 Patient Sequence Number: 1
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