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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 Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)
Event Date 07/18/2023
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.There is no information to indicate that a malfunction occurred.Allergic or adverse reactions are known risks of hemodialysis.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.Biocompatibility of the device has been established.
 
Event Description
A report was received on (b)(6) 2023 from the caregiver of a 52 year old male patient with a medical history including hypertension and end stage renal disease who stated the patient previously had a hypersensitivity type response during hemodialysis therapy, date not provided.Additional information was received on 06 oct 2023 from the home therapy nurse (htn), who stated the patient experienced generalized urticaria within five minutes of beginning his first in-center hemodialysis treatment on (b)(6) 2023.Per the htn, the patient was treated with 25mg of intravenous diphenhydramine (benadryl) and symptoms resolved.The patient continues to with nxstage therapy and no further hypersensitivity type reactions have been reported.
 
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Brand Name
NXSTAGE SYSTEM ONE
Type of Device
HIGH 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 Key17948375
MDR Text Key325800243
Report Number3003464075-2023-00090
Device Sequence Number1
Product Code KDI
UDI-Device IdentifierM535CAR170C0
UDI-Public+M535CAR170C0/$$0624302770193
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/01/2024
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number30277019
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient SexMale
Patient Weight83 KG
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