MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number CAR-505

Device Problems Material Puncture/Hole (1504); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

Per staff, when using a nxstage crrt circuit, it was discovered that the saline connection fused.In addition, the bag had a hole in it.The circuit was replaced with a new set and continued as planned with no harm to the patient.

• Brand Name: NXSTAGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 10091566
• MDR Text Key: 192196312
• Report Number: 10091566
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CAR-505
• Device Lot Number: 910780009
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 85