MAUDE Adverse Event Report: AMBU INC. ACTION FUSER PUMP; PUMP, INFUSION

Catalog Number 419 1056 50

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

This pump was being used to pain control, the bulb was inside the pouch for the pt to wear home.Prior to dischage, mom reported the pouch exploded.No patient harm.Unknown what caused the event.

• Brand Name: ACTION FUSER PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): AMBU INC.; 6740 baymeadow drive; glen burnie MD 21060
• MDR Report Key: 4066494
• MDR Text Key: 4810204
• Report Number: 4066494
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/29/2014

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: Invalid Data
• Device Catalogue Number: 419 1056 50
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2014
• Patient Sequence Number: 1
• Patient Age: 16 YR