MAUDE Adverse Event Report: BELLCO SRL MOZARC MEDICAL CARPEDIEM; PEDIATRIC HEMODIALYSIS SYSTEM

Model Number CARPEDIEM

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

Event Date 01/09/2024

Event Type  Injury  

Event Description

Carpediem crrt (continuous renal replacement therapy) machine was connected to critically ill patient and delivering therapy.About 1.5 hours into the treatment, it was noted that the screen intermittently turned white and flickering with no patient or machine data available.Values would appear for a moment and then screen would go white again.Medtronic clinical support called - advised that the light bulb in the screen was going out and the pump screen would likely completely fail within one hour.Per clinical support, it was optional to continue therapy as pumps were still running but no alarm or treatment data would be visible.Decision made to discontinue treatment with the device as not deemed safe.Therapy ended per standard procedure - buttons selected when screen was intermittently available.Of note, screens were replaced on 2 of our 3 carpediem machines in august 2023 (not this machine) due to similar issue discovered during monthly checks.At that time, it was requested that medtronic also replace the screen on this device as they were all purchased together - medtronic service division elected not to do so as the issue had not occurred with this machine.This type of carpediem screen failure has occurred and been reported by other institutions to medtronic and the fda.

• Brand Name: MOZARC MEDICAL CARPEDIEM
• Type of Device: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): BELLCO SRL
• MDR Report Key: 18518189
• MDR Text Key: 333090496
• Report Number: MW5150217
• Device Sequence Number: 1
• Product Code: QIR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2024

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: CARPEDIEM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White