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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 Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Nausea (1970); Reaction (2414); Diaphoresis (2452); Shaking/Tremors (2515)
Event Date 07/02/2020
Event Type  Injury  
Manufacturer Narrative
The patient experienced a similar adverse event with the same device model number on (b)(6) 2020. The event is documented in mfr report # 3003464075-2020-00041. The patient experienced a similar adverse event with the same device model number on (b)(6) 2020. The event is documented in mfr report # 3003464075-2020-00043. 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 13 jul 2020 from the home therapy nurse (htn) of a (b)(6) year old female patient, with a medical history of renal osteodystrophy, secondary hyperparathyroidism, diverticulitis, end stage renal disease and an adverse reaction during hemodialysis treatment the previous day, stating patient had an adverse reaction during her second hemodialysis session with the device on (b)(6) 2020. Additional information was received on 16 jul 2020 from the htn who stated symptoms began twenty five minutes into treatment and included nausea, abdominal pain, diaphoresis, shaking and blood pressure decrease from 121/91 mmhg to 94/48 mmhg. The patient was given 2 l/min of oxygen per nasal cannula and 25mg diphenhydramine iv, and treatment was terminated without rinseback. Symptoms resolved within fifteen minutes of diphenhydramine administration and no other medical intervention was reported.
 
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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 Key10340623
MDR Text Key201558273
Report Number3003464075-2020-00042
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 01/01/2005,07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2022
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number00577021
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 Received07/13/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/29/2020 Patient Sequence Number: 1
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