MAUDE Adverse Event Report: I-FLOW ON-Q PUMP WITH ONDEMAND BOLUS BUTTON

Model Number CB006

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

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

Event Date 10/14/2014

Event Type  malfunction  

Event Description

On-q pump with ropivacaine 0.2% had an on demand bolus button malfunction (did not latch into place) and did not deliver the 5 ml dose over 30 minutes.Despite the efforts of pharmacy and nursing staff to correct and troubleshoot, the device would not work properly.A second on-q pump within the same lot number was attempted and resulted in the same bolus button malfunction.A third on-q pump from a different lot number was attempted and worked properly.

• Brand Name: ON-Q PUMP WITH ONDEMAND BOLUS BUTTON
• Type of Device: ON-Q PUMP WITH ONDEMAND BOLUS BUTTON
• Manufacturer (Section D): I-FLOW; lake forest CA 92630
• MDR Report Key: 4189835
• MDR Text Key: 21882667
• Report Number: MW5038669
• Device Sequence Number: 1
• Product Code: MEB
• 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: 10/15/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: CB006
• Device Catalogue Number: 101347400
• Device Lot Number: 0200991709
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 111