MAUDE Adverse Event Report: AMBU ACTIONBLOC

Model Number 418000650

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2015

Event Type  malfunction  

Event Description

Patient had bilateral paravertebral nerve blocks placed three days prior during a nuss procedure.Attempt was made to replace empty local anesthetic reservoir with a fresh one.The connector on the new reservoir (male luer lock) did not match the connector (also male) on the flow regulator of the product.The only way the reservoir could be connected was to bypass the flow regulator and connect the reservoir directly to the nerve block catheter (which had a female luer lock connector).This product (ambu actionbloc) was previously implicated in a patient death (maude mdr report key 3929747) because of improper connections (reservoir directly to catheter).Ambu redesigned the product so that the reservoir should have a female luer lock connector.However, the product that ambu is currently shipping continues to have a male luer lock connector, placing the patient at risk for improper connection.

• Brand Name: ACTIONBLOC
• Type of Device: ACTIONBLOC
• Manufacturer (Section D): AMBU
• MDR Report Key: 4925240
• MDR Text Key: 17220168
• Report Number: MW5044444
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2015

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 Expiration Date: 02/28/2017
• Device Model Number: 418000650
• Device Catalogue Number: 418000650
• Device Lot Number: 16940801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 68