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

Model Number CAR-172-C

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943)

Event Date 09/21/2020

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 (b)(6) 2020 from the home therapy nurse (htn) of a (b)(6) year old female with a medical history of diabetes and end stage renal disease, stating the patient experienced a hypersensitivity type reaction during their first hemodialysis treatment with the nxstage system on (b)(6) 2020.Symptoms included developing itchiness of the skin and throat with mucosal inflammation.Additional information was received 22-24 sep 2020 from the htn stating symptoms onset approximately 2 minutes after initiating treatment.Administration of 25mg intravenous (iv) and 25mg oral (p.O.) benadryl were provided, symptoms subsided, and the treatment session was completed.

• 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: 10612815
• MDR Text Key: 209366703
• Report Number: 3003464075-2020-00067
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$122100377030X
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 00377030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 93