MAUDE Adverse Event Report: BELLCO SRL CARPEDIEM CARDIO RENAL PEDIATRIC DIALYSIS EMERGENCY MACHINE; PEDIATRIC HEMODIALYSIS SYSTEM

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Event Description

Carpediem crrt machine was connected to critically ill patient and delivering therapy.A couple hours into the treatment it was noted that the screen intermittently turned white and flickered with no patient or machine data available.Wall plug was adjusted and screen seemed to return to function.Medtronic clinical support called - advised that the light bulb in the screen was going out and advised to continue to run until screen failure.Several hours later, screen went completely black.Medtronic therapy specialist called and therapy ended per their direction.New circuit initiated on new machine with new blood prime.(b)(6) medical.(b)(6).

• Brand Name: CARPEDIEM CARDIO RENAL PEDIATRIC DIALYSIS EMERGENCY MACHINE
• Type of Device: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): BELLCO SRL
• MDR Report Key: 18623179
• MDR Text Key: 334490376
• Report Number: MW5150955
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 DA
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White