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

Lot Number 19471805

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/26/2017

Event Type  Injury  

Event Description

Problem with ambu action block device.There were two devices that emptied in about 48 hours and should have lasted at least 70 hours.The lot for the two devices is 19471805.One bag was filled to 550ml and the flow rate was looked at 7ml/hr and the other bag was filled to 375ml and set to 5ml/hr.The pt was always inpatient and we had to change products before she went home.Let me know what other info you need from me.

• Brand Name: AMBU ACTION BLOCK PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AMBU INC.
• MDR Report Key: 6995778
• MDR Text Key: 90931110
• Report Number: MW5073082
• Device Sequence Number: 2
• 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: 10/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 19471805
• 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 Outcome(s): Required Intervention