MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT SPACE PUMP IV SET TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 363230

Device Problem Fluid/Blood Leak (1250)

Patient Problem Underdose (2542)

Event Date 06/21/2019

Event Type  malfunction  

Event Description

At 1525 the rn noticed that there were 2 drops of the pt's infusion leaking around the middle port/connector of the b.Braun tubing.The infusing medication was venofer.Upon further assessment, it was determined that there was leaking occurring around this site, so the infusion was stopped and the provider was notified.The pt had no harm or evidence of spill on or around them.The pt only missed about 9% of his intended dose, or about 23cc of the medication.

• Brand Name: INFUSOMAT SPACE PUMP IV SET TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 8772806
• MDR Text Key: 150620164
• Report Number: MW5087968
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 363230
• Device Catalogue Number: 363230
• Device Lot Number: 0061669507
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR