MAUDE Adverse Event Report: I-FLOW LLC ON-Q : PUMP 400 ML, 1-7 ML/HR SELECT A FLOW +5 ML

Model Number P400X1-7+5/60

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Fill volume 600 ml.Flow rate 6 ml/hr.Procedure: total knee surgery.Cathplace: femoral nerve block.Infusion start time: (b)(6) 2014 approx 10 or 11 am.Infusion end time: (b)(6) 2014 approx 4:30 pm.A pharmacist reported that the on demand bolus button of a medication infusion pump was stuck down with the orange indicator at the bottom of the bolus chamber.It was unk how long the bolus button was stuck.The pt was then instructed to clamp the pump.After 45 minutes of the pump being clamped, the bolus button still did not pop up and the orange indicator remained at the bottom of the bolus chamber.The pump was disconnected and was replaced with a new one from the pharmacy.The pt did not experience any adverse events.

Manufacturer Narrative

The device has been received and a visual inspection has been conducted.At this time testing is currently in progress.A review of the device history record (dhr) is in progress.Eval and investigation and testing are ongoing, once completed a follow up will be submitted.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.

• Brand Name: ON-Q : PUMP 400 ML, 1-7 ML/HR SELECT A FLOW +5 ML
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4239242
• MDR Text Key: 5071139
• Report Number: 2026095-2014-00205
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: P400X1-7+5/60
• Device Catalogue Number: 101368400
• Device Lot Number: 0201324680
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 0.2% ROPIVICAINE
• Patient Age: 64 YR
• Patient Weight: 109