MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number CAR-170-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Reaction (2414); Sweating (2444); Shaking/Tremors (2515)

Event Date 07/13/2020

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 # 3003464075-2020-00042.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 (b)(6) 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 two recent hypersensitivity type reactions during hemodialysis treatments, stating the patient had an adverse reaction during hemodialysis therapy 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 pains, diaphoresis, shaking and blood pressure decrease from 122/90 mmhg to 101/51 mmhg.The patient was given 2 l/min of oxygen per nasal cannula and 25mg diphenhydramine iv and treatment was terminated without rinseback.The patient recovered without sequelae within fifteen minutes of diphenhydramine administration.Per the htn, further hemodialysis treatments will be performed with a device from a different manufacturer.

• 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 Key: 10340856
• MDR Text Key: 208208297
• Report Number: 3003464075-2020-00043
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$0121905770150
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• 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 Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 90577015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 91