MAUDE Adverse Event Report: AMBU INC. / MEDICAL FLOW SYSTEMS LTD AMBU ACTION BLOCK PAIN PUMP; PUMP, INFUSION, ELASTOMERIC

Lot Number 20471801

Device Problem No Flow (2991)

Patient Problem Missed Dose (2561)

Event Date 07/16/2018

Event Type  Injury  

Event Description

Ambupump with ropivacaine 0.2% failed to infuse medication.Lines checked and connected/functioning properly but medication was not being delivered to the pt.

• Brand Name: AMBU ACTION BLOCK PAIN PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AMBU INC. / MEDICAL FLOW SYSTEMS LTD; columbia MD 21045
• MDR Report Key: 7717903
• MDR Text Key: 115088422
• Report Number: MW5078581
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/19/2018

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 Lot Number: 20471801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 34