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

Lot Number 20578002

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Cvvh machine alarmed for "blood leak".There was no blood leak noted.Instructions followed on machine which said after 2 attempts at restarting if it didn't work replace the cartridge.Blood was returned to patient.The cartridge was exchanged.Manufacturer response for cvvh cartridge, (brand not provided) (per site reporter) no report to date.

• Brand Name: NXSTAGE CARTRIDGE
• 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: 15758919
• MDR Text Key: 303310988
• Report Number: 15758919
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20578002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29565 DA
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic