MAUDE Adverse Event Report: I-FLOW, LLC ON-Q C BLOC: 400 ML, 5ML/HR; ELASTOMERIC PUMP

Model Number CB001

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

Patient Problems Dizziness (2194); Numbness (2415); Palpitations (2467)

Event Date 08/27/2014

Event Type  Injury  

Event Description

Fill volume: 400 ml.Flow rate: 5 ml/hr.Procedure: c-section.Cathplace: incisional.A female pt, who is a nurse herself, reported that she experienced local anesthetic reactions from using an on-q pump.The pt underwent a c-section surgery on (b)(6) 2014.The pt described her symptoms as "experiencing numbness in her hands, legs, out side of her body and feet, heart racing, dizziness, chills and sweatiness and felt like she will pass out at times".Additional info was received and the pt reported that on (b)(6) 2014 she again experienced similar symptoms when the flow restrictor was near her body.Therefore, she removed her on-q pump and silver soaker catheter with the tip intact.However, when she would walk around and the flow restrictor was away from her body she would feel a lot better.The pump was filled on (b)(6) 2014 prior to surgery and infusion was started at 12:45 pm.On (b)(6) 2014, at approximately 5:15 pm, the pt discontinued infusion.

Manufacturer Narrative

Method: the device was received for analysis and a visual inspection was performed.A review of the device history record (dhr) was conducted for the lot number received on the pump.Results: at this time the eval is still in progress.Results will be provided once completed.Per the dhr review there were no reworks, special conditions, or related nonconformance reports (ncrs) for this reported lot number.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Info from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: ON-Q C BLOC: 400 ML, 5ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4124991
• MDR Text Key: 4947604
• Report Number: 2026095-2014-00185
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: CB001
• Device Catalogue Number: 101346700
• Device Lot Number: 0200940105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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: MARCAINE 0.5%
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 66