MAUDE Adverse Event Report: AMBU AMBU ACTION PUMP

Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  Injury  

Event Description

Right arthroplasty total knee performed on (b)(6) 2016.Ambulation pump containing 600 ml ropivacaine 0.2% started at 8 ml at 11:20.Pump was obtained from pharmedium lot 16287045s, and dispensed by our hospital pharmacy.On (b)(6) 2016 at approx 10:15, the pt's nurse noticed on routine check that the pump was empty.Both pa and anesthesiologist verified that pump was empty.Pt's dressing was clean/dry/intact with no leakage noted.Pt did not experience any signs of symptoms of toxicity, but pt was transferred to the imcu for observation given potential gravity of local anesthetic toxicity.No cardiac or neurological signs of toxicity were noted, and pt was discharged.

• Brand Name: AMBU ACTION PUMP
• Type of Device: AMBU ACTION PUMP
• Manufacturer (Section D): AMBU
• MDR Report Key: 6185567
• MDR Text Key: 62858235
• Report Number: MW5066762
• Device Sequence Number: 1
• Product Code: BZK
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 112