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

Lot Number 20578001, 20478002, 2057800

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Cvvh (continuous veno-venous hemofiltration) tubing found to be kinked or flattened out when new tubing is being attached.There were four attempts to get a good set on this particular patient.This is from 3 different lots: 20578001, 20478002 and 20578002.The hospital is moving to a new model which the vendor rep notes has fewer issues.Manufacturer response for cvvh cartridge, acute care cartridge (per site reporter) no report to date.

• Brand Name: ACUTE CARE 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: 15758937
• MDR Text Key: 303314230
• Report Number: 15758937
• 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

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20578001, 20478002, 2057800
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22995 DA
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White