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

Patient Problem Insufficient Information (4580)

Event Date 01/28/2024

Event Type  Injury  

Event Description

Carpediem crrt machine was connected to critically ill patient and delivering therapy.A couple hours into the treatment the screen went black.Medtronic clinical support called - advised that screen had failed.Blood pump was still running and pump alarms were functional.New machine set up - no alarms in connected machine during prep.Medtronic therapy specialist called and treatment ended per their direction.(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: 18622758
• MDR Text Key: 334437288
• Report Number: MW5150953
• 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: 23 DA
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White