MAUDE Adverse Event Report: I-FLOW LLC ON-Q C-BLOC: 60ML, 2-14ML/HR, SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number CB6004

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

Patient Problem Incontinence (1928)

Event Date 02/16/2014

Event Type  malfunction  

Event Description

Drug/diluent: 0.25% bupivacaine, fill volume: 600 ml, flow rate: 12 ml/hr (initially) and 13 ml/hr, procedure: right total shoulder replacement, cathplace: interscalene block; upper right shoulder, date of surgery: (b)(6) 2014.The patient's son phoned the product support line and would like to know if he should keep the pump off.His mother had a right total shoulder replacement on friday (b)(6) 2014.Now she is experiencing urinary incontinence.Son turned rate to 0 about 20 min ago (20min before calling the hotline, call was received at 6:06am).Patient is urinating about every hour moderate amount and per son she doesn't intake too many fluids (drink).She can not hold urine and was incontinent on a few occasions.Agreed to keep pump rate at 0ml/hr.Patient took 2 tabs of oxycodone within the last 2 hours for some discomfort.Pump's rate was 12ml/hr before it was turned to 0ml/hr.He doesn't exactly know when these symptoms started.When a family member was caring for her the rate of flow was increased to 13ml/hr.Son does not know how long the pump was infusing at this rate but, before it was turned to 0 it was at 12ml/hr.Hot line nurse explained to the son that he has to make sure that the pump is set directly at a number which must be lined up with the black triangle.Advised to call the anesthesiologist and continue to keep pump off.If symptoms subside, it was the medication causing these symptoms.Hot line nurse followed up at 11:32am on (b)(6) 2014 and spoke to patient's son he mentioned that he spoke to two anesthesiologists who advised him to keep the pump's rate on low 2, 4 or 6ml/hr.Med said that the can take it out if he wants but if the patient has pain, lower flow rate should be sufficient to treat the pain and stay away from developing the symptoms again.Son states that mom's (patient) symptoms are resolved and she is much better at this time.He was glad to know that they can not turn the pump in between numbers.He is making sure that other care takers are also aware of this.Patient took additional 1-tab of oxycodone since hot line nurse spoke to them last at 6am.Total tabs of oxycodone within the last 18-20hrs is 3-tabs.

Manufacturer Narrative

Method: the device was received for an evaluation and investigation.A visual examination was performed on the returned unit.Currently the device history review (dhr) is in progress.Results: at this time the evaluation is still in progress.Results will be provided once completed.Conclusions: the symptoms reported may be secondary to a reaction from the medication, but there is an inability to rule out device malfunction at this time.A conclusion is not yet available as the investigation and evaluation of the product is still in progress, and has not been completed.Once completed a follow-up report will be submitted.Information from this incident will be included 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: 60ML, 2-14ML/HR, SELECT-A-FLOW
• 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: 3847147
• MDR Text Key: 4685557
• Report Number: 2026095-2014-00029
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/16/2014

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: 04/30/2016
• Device Model Number: CB6004
• Device Catalogue Number: 101347600
• Device Lot Number: 0201221120
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ARROW BRAND CATHETER WAS USED WITH THE PUMP; OXYCODONE - 3 TABS (UNK DOSAGE)
• Patient Age: 72 YR
• Patient Weight: 65