MAUDE Adverse Event Report: I-FLOW, LLC ON-Q PAINBUSTER: SOAKER 5IN:270ML, DUAL, 2+2ML/HR; ELASTOMERIC PUMP

Model Number PM025

Device Problem Infusion or Flow Problem (2964)

Patient Problems Anxiety (2328); Reaction (2414)

Event Date 09/19/2014

Event Type  Injury  

Event Description

Fill volume: 300 ml.Flow rate: 2 ml/hr x 2.Procedure: abdominoplasty.Cathplace: abdomen.The female pt had abdominoplasty on (b)(6) 2014.The physician later reported a fast flow incident.The physician stated that the pt called the office less than 24 hrs after abdominoplasty surgery to report that her on-q pump was almost empty.In addition, the pt reported to the doctor that she was experiencing anxiety and a funny taste in her mouth.The pt was seen at the physician's office and the pump was removed.The physician stated that no medical intervention was given to the pt and reported the pt status as "fine." infusion began on the same day as the surgery ((b)(6) 2014) at 11:30 am.There were no interruptions during the infusion and on (b)(6) 2014 at 1:30 pm, the infusion ended.The physician stated that the pump was "almost empty" when the pump was removed.

Manufacturer Narrative

Method: the device was received for analysis.A visual inspection was performed on the returned device.Testing and analysis are in progress.A review of the device history record (dhr) is in progress.Results: there are no results available as the investigation and eval are currently in progress.Conclusions: once the analysis and investigation 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 PAINBUSTER: SOAKER 5IN:270ML, DUAL, 2+2ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4189079
• MDR Text Key: 5161158
• Report Number: 2026095-2014-00198
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: PM025
• Device Catalogue Number: 101364000
• Device Lot Number: 0201440429
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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: DRUG: BUPIVICAINE 0.5%
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 80