MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number CB004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Tachycardia (2095); Blurred Vision (2137); Chills (2191); Anxiety (2328)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Fill volume: 500ml.Flow rate: 10ml/hr.Procedure: robotic colectomy.Cathplace: tap.Please reference: 2026095-2015-00004/(b)(4).Pump #1 of 2.A pt reported experiencing worsening of symptoms from local anesthetic while using 2 pumps.The pt experienced several episode of chills, blurred vision, increased heart rate (hr), and anxiety while in the hosp.The infusion began at that time with unspecified pumps.The symptoms were intermittent (not constant) while hospitalized.The pt stated that different devices were used at facility to infuse anesthetic.On (b)(6) 2014, the on-q pumps were placed prior to discharge.Upon discharge, the side effects became constant and worsened.The pt was treated with an unspecified anti-anxiety medication; however, the symptoms did not resolve after taking the medication.It was reported that the pt experienced the symptoms for 3 days at various times.The pt was instructed to clamp the pumps and notify the surgeon.The pt followed up with the physician who instructed the pt to remove the pumps.The infusion ended at that time on (b)(6) 2014.Upon removal, the pumps were not empty and contained most of the medication.Within the hr, the symptoms subsided.The device was saved for return.

Manufacturer Narrative

Method: 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) is in progress for the reported lot number.Results: at this time, halyard is pending the receipt of the device and as the investigation is still in progress, results are not available.Once the device is received, testing will be performed and results will be provided upon completion.Conclusions: once the investigation and device analysis are completed, a f/u 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 add'l investigations.

• Brand Name: ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4420696
• MDR Text Key: 5377836
• Report Number: 2026095-2015-00003
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0201097945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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 0.1%; TYLENOL 2 TABLETS
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 91