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

Model Number IB7010250

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

Event Date 12/10/2023

Event Type  malfunction  

Event Description

Upon changing the effluent bag, the machine read that the effluent bag was leaking, and the screen began to flicker.The screen fluctuated between flickering and appearing fuzzy.During this time, they were unable to see anything on the screen or operate the machine.After a few minutes, the screen resumed to normal, and dialysis resumed.

• Brand Name: CARPEDIEM
• Type of Device: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): BELLCO SRL; 710 medtronic parkway (lt140); minneapolis MN 55432
• MDR Report Key: 18502255
• MDR Text Key: 332767336
• Report Number: 18502255
• Device Sequence Number: 1
• Product Code: QIR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IB7010250
• 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: 12/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic