MAUDE Adverse Event Report: HALYARD ON-Q PUMP SELECT-A-FLOW + ONDEMAND; ELASTOMERIC PUMP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Reaction (2414)

Event Date 02/04/2015

Event Type  Injury  

Event Description

Fill volume: 500ml.Flow rate: 6ml/hr.Procedure: left total ankle arthroplasty.Cathplace: sciatic nerve.It was reported that an on-q pump had a stuck bolus button during patient use.Additional information was received on 02/05/2015.A nurse reported that the patient was sent home on (b)(6) 2015 with the pump and the sciatic catheter.The incident occurred overnight in the patient's home.The patient contacted the aps (acute pain service) after noting that the bolus button did not refill after pushing it down.It was maintained in a down (open position and the patient received a continuous infusion (volume undetermined).The patient experienced metallic taste in the mouth.The patient discontinued the catheter and went to the emergency room for pain management with unspecified opiates.The nurse confirmed that the button would not latch/push down.At the time of this report the patient is being treated for pain management, however, the patient is reported as stable.The pump has been saved to return and evaluate.Additional information was received 02/12/2015.The flow rate was never changed.The button was pushed 3 times.The bolus refill indicator was at the lower position.

Manufacturer Narrative

Method: the device was reported to be returning for an evaluation and at this time is pending return.As a lot number was not reported, a review of the device history record (dhr) will not be conducted until the actual device is received with a lot number on the device.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a follow up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q PUMP SELECT-A-FLOW + ONDEMAND
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4553440
• MDR Text Key: 5521900
• Report Number: 2026095-2015-00081
• 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: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRUG: ROPIVACAINE 02.%
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 93