MAUDE Adverse Event Report: HALYARD ON-Q PUMP 400 ML 2-14 ML/HR SAF + 5 ML/ 30 MIN

Model Number CB006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

Fill volume 550 ml.It was reported that the bolus button on a bolus device would not pop up.The orange refill indicator on the bolus device was in the bottom position.Additional info was requested; however, it is not available at this time.It was reported that there was no pt involvement.The device is available for return and analysis.

Manufacturer Narrative

The device was reported to be returning for an eval and at this time is pending return.A review of the device history record (dhr) was conducted for the reported lot number.At this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provide once completed; however, a dhr review was performed and indicated that there were no reworks, special conditions, or related nonconformity reports (ncrs) for this reported lot number.The lot met the process specifications, including the quality control acceptance criteria prior to release.Once the investigation and device analysis are completed a follow up report 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 2-14 ML/HR SAF + 5 ML/ 30 MIN
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discover ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4535611
• MDR Text Key: 21081005
• Report Number: 2026095-2015-00073
• 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,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: CB006
• Device Catalogue Number: 101347403
• Device Lot Number: 0201320366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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: ROPIVACAINE 0.2%