MAUDE Adverse Event Report: AMBU INC ACTION BLOCK PUMP; PUMP, INFUSION, ELASTOMERIC

Lot Number 18471804

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/12/2017

Event Type  malfunction  

Event Description

Went to patient bedside, found ambu ball tubing was dislodged from filter site.Paged pain service, received order to disconnect the ambu ball.Removed ambu ball.Manufacturer response for ambu action block pump pain disposable pain management, (brand not provided) (per site reporter): immediate response.Questions and follow up done.Stated that depending on the lot number - this might be an old lot number that was not involved with new changes that have been made in the bonding process of manufacturing.

• Brand Name: ACTION BLOCK PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AMBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• MDR Report Key: 6431542
• MDR Text Key: 70781055
• Report Number: 6431542
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 18471804
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1