MAUDE Adverse Event Report: I-FLOW LLC ON-Q C-BLOC: 400 ML, 2-14 ML/HR, SAF; ELASTOMERIC PUMP

Model Number CB004

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 02/08/2014

Event Type  Injury  

Event Description

Drug/diluent: 0.2% bupivacaine.Fill volume: 400 ml.Flow rate: 4 ml/hr (initially) 6 ml/hr.Procedure: rotator cuff surgery.Cathplace: brachial plexus block.Date of surgery: (b)(6) 2014.Summary of incident: the patient's wife contacted the product support hotline due to the patient having difficulty swallowing.It was reported this symptom started 36 hours after the surgery.No difficulty in breathing was reported.The pump was started at 4 ml/hr and then increased to 6 ml/hr.Incident as received: "wife calls because patient has hard time swallowing.He had rotator cuff surgery yesterday (b)(6) 2014 and flow rate was set at 4 ml/hr.He was in pain earlier today and so they increased rate to 6 ml/hr.His catheter sits around the neck area per wife.A few hours after the rate increase the patient started to feel like his throat is swelling.Per wife he has difficulty swallowing, but his breathing is normal.{2026095-2014-00027/2014-00131} wife states that patient is in no respiratory distress.I can also hear patient talking normally in the background.Advised wife to clamp the pump and to call their anesthesiologist for further instructions.Wife asked if she should go to e.R.Or call 911.Explained that this is up to her discretion, but if she feels like that her husband is in an imminent distress, she should call 911.If not she can take him to the e.R.Explained that pump is stopped now and that he is not receiving any more medication, but it will take about an hour to see the symptoms subside.Attempted to collect information about patient's medical history and medication, as well as lot number of the pump and address for return kit, but wife said she does not have time for this and hung up." date (b)(6) 2014, additional info: surgery nurse was contacted and reported the patient was taken to e.R.And received steroid benedryl, but the infusion was continued at 4 ml per hour.Patient's wife was contacted and reported that she took the patient to e.R.On (b)(6) 2014 as "his throat was closing up." he received i.V.Steroid and benedryl at the e.R.And the symptom went away a few hours.The anesthesiologist recommended to either remove the pump or keep the pump at 4 ml/hr.The patient seemed to be tolerating well when the infusion rate was set at 4 ml/hr.The patient's wife discontinued the pump today at around 1 pm as she was told discontinue the pump after 72 hours.The pump still has medication inside.Our sales rep.Spoke to the anesthesiologist and it was reported that the anesthesiologist suggested the feeling of the throat was closing up was most likely due to the intubation for general anesthesia and the pump was not the issue.Date (b)(6) 2013, additional info: patient had his post-op and it was unremarkable and is in physical therapy.

Manufacturer Narrative

Method: at this time we are currently pending the return of the device.A review of the device history record (dhr) was conducted for the lot number provided.Results: per the dhr review the device passed all manufacturing specifications at release.Results are pending the completion of the evaluation and investigation.Conclusions: the device will be evaluated once received to determine any cause.A follow up report will be filed when the investigation has been completed.Information from this incident will be concluded in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.

• Brand Name: ON-Q C-BLOC: 400 ML, 2-14 ML/HR, SAF
• 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: 3677323
• MDR Text Key: 4291318
• Report Number: 2026095-2014-00027
• 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: 02/08/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0201173495
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2014
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 95