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

Model Number NX1000-5-A

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306); Device Fell (4014)

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

Event Date 02/20/2022

Event Type  malfunction  

Event Description

While nurse was touching display to do hourly numbers, the machine fell off the stand onto nurse.Nurse was able to stabilize the machine on a chair in the room and blood was returned to the patient safely.There was no injury to the nurse or the patient but therapy was interrupted.The machine is attached to the stand with three thumb nuts, two on the top and one on the bottom.All three nuts on this machine were missing and had apparently vibrated loose and fell off.Inspection of other machines found several loose or missing nuts.The machines are subject to frequent moving, including elevators, which can cause the nuts to loosen.The thumb nuts are intended to make servicing the machine easier, but don't have any kind of locking mechanism.

• Brand Name: NXSTAGE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 13710183
• MDR Text Key: 286855718
• Report Number: 13710183
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2022

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 Model Number: NX1000-5-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female