MAUDE Adverse Event Report: BBRAUN INFUSOMAT SPACE BLOOD TUBING

Model Number 363419

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/26/2014

Event Type  Injury  

Event Description

During a transfusion of packed red blood cells, after the blood had been infusing for approximately 1.5 hours, blood was found to be leaking out of the iv pump.Upon inspection, it was noted that there was blood leaking from the segment of the tubing that goes in the pump.Precisely, it was leaking at the junction of the white pump clip and the rest of the tubing.

• Brand Name: INFUSOMAT SPACE BLOOD TUBING
• Type of Device: BLOOD TUBING
• Manufacturer (Section D): BBRAUN; mississauga
• MDR Report Key: 4317311
• MDR Text Key: 18270148
• Report Number: MW5039431
• Device Sequence Number: 1
• Product Code: BRZ
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2014

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
• Device Model Number: 363419
• Device Lot Number: 0061381033
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention