MAUDE Adverse Event Report: ON-Q PUMP

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

On-q pump connected to peripheral iv by pt.Recently in our organization, a pt recovering from an orthopedic procedure connected his on-q pump to a peripheral iv.Fortunately this was immediately identified by the pt's rn.Anesthesia was notified, the pt was monitored, and the on-q pump was discontinued due to concern for compliance.We reviewed this event in a multi-disciplinary forum in an effort to prevent recurrence.We also reached out to the mfr secondary to concerns for the luer connector's compatibility with standard iv tubing.Unfortunately, per the mfr currently there is not an alternative to the luer lock connection on the tubing.I know this is something ismp has reported on previously in 2012 and i think it is worth repeating considering the risk is still out there.Increased awareness of pt safety concerns is significant in helping to reduce the likelihood of recurrence."medication administered to or used by the pt: yes.When and how was error discovered: fortunately this was immediately identified by the pt's rn." (b)(4).

• Brand Name: ON-Q PUMP
• Type of Device: ON-Q PUMP
• MDR Report Key: 6785151
• MDR Text Key: 82565110
• Report Number: MW5071487
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2017

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1