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

Model Number CAR-172-C

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Photos of the device were received and reviewed, confirming the presence of a broken luer.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.The cause of a broken/damaged luer connector may be due to excessive force.Nxstage disposable products include standard luer components widely used throughout dialysis industry.A review of the complaint database revealed no other similar reports for this cartridge lot number.

Event Description

A report was received on 31 oct 2019 regarding a (b)(6) year old female, stating the cartridge arterial line luer broke within the patient's central venous catheter during a nocturnal home hemodialysis treatment on (b)(6) 2019.Additional information was received on 06 nov 2019 from the home therapy nurse (htn) stating the patient was admitted to hospital (b)(6) 2019 to undergo a catheter repair.The patient was discharged from hospital on (b)(6) 2019 with a diagnosis of line repair.After hospital discharge the patient performed a dialysis treatment in-center to receive antibiotic coverage, 100mg gentamycin iv and 1g vacomycin iv.The patient recovered without sequelae and continues to treat using the nxstage system at home.

• 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: 9293508
• MDR Text Key: 219213831
• Report Number: 3003464075-2019-00059
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0221906770042
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 90677004
• Was Device Available for Evaluation?: No
• 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: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR