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

Model Number CAR-505

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2021

Event Type  malfunction  

Event Description

Luer connector for the cartridge became separated from the blood lines after connection to the ecmo circuit.Stopcock was not yet open to start blood flow.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimak st.; lawrence MA 01843
• MDR Report Key: 11892998
• MDR Text Key: 252914138
• Report Number: 11892998
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-505
• Device Lot Number: 10178005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Weight: 74