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

Model Number CAR-500

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2018

Event Type  malfunction  

Event Description

The patient was receiving cvvh (continuous veno-venous hemofiltration) and the cassette that was placed in the machine had a hole in the seam of the bladder causing it to leak water.Realized as i was entering device info that the device is expired.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• 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: 8114691
• MDR Text Key: 128756856
• Report Number: 8114691
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 70278006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Weight: 69