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

Model Number CARPEDIEM 110-120 VAC-US

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

Device screen was found to be black and nonfunctional when powered on.This was discovered spontaneously when the machine was powered on so did not impact a patient.Screens on both machines required replacement by manufacturer.Reference report: mw5148071.

• Brand Name: MEDTRONIC/MOZARC MEDICAL CARPEDIEM
• Type of Device: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): MOZARC MEDICAL/BELLCO SRL; minneapolis MN 55423
• MDR Report Key: 18130009
• MDR Text Key: 328350541
• Report Number: MW5148070
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARPEDIEM 110-120 VAC-US
• Device Catalogue Number: M410000B006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1