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

Model Number 41902650

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 10/25/2019

Event Type  malfunction  

Event Description

There were two incidents in which an ambu action block pain pump ruptured / burst prior to attachment to the pt.The ambu pump has a 650 ml reservoir and was filled with 650 ml of ropivacaine 0.2%.The incident happened hours after pharmacy filled it but the second incident occurred thirty mins after it was filled.In the second incident, the elastomeric pump ruptured while sitting on the counter at room temperature.After bursting, the ropivacaine solution immediately leaked out of the bag at a very high rate.It looks like the inner and outer lining of the pump is ripped.Fda safety report id# (b)(4).

• Brand Name: AMBU ACTION BLOCK PAIN PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AMBU INC. ; columbia MD 21045
• MDR Report Key: 9260288
• MDR Text Key: 164671276
• Report Number: MW5090776
• 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: 10/28/2019

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 Model Number: 41902650
• Device Catalogue Number: 419102650
• Device Lot Number: 20471811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• 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
• Patient Age: 12 YR
• Patient Weight: 53