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

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

Carpediem machine was connected to patient and delivering therapy.Screen started flickering and went black.Therapy had to be discontinued without obtaining final numbers from treatment and exposed to new blood product in prime.For this patient with renal agenesis, minimizing blood exposure is critical to long term outcome as patient is being supported by dialysis until able to receive kidney transplant.

• Brand Name: MOZARC MEDICAL CARPEDIEM
• Type of Device: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): MOZARC MEDICAL / BELLCO SRL; minneapolis MN 55432
• MDR Report Key: 19089378
• MDR Text Key: 340104209
• Report Number: MW5153730
• Device Sequence Number: 1
• Product Code: QIR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic
• Patient Race: White