MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP 270ML, 4ML/HR (2+2 DUAL SITE); ELASTOMERIC PUMP

Model Number P270X4D

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

Patient Problems Nausea (1970); Respiratory Distress (2045); Tinnitus (2103); Vomiting (2144); Reaction (2414)

Event Date 07/03/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

Flow rate: 4ml/hr.Procedure: hernia surgery ((b)(6) 2015).Cathplace: upper stomach.Infusion started: (b)(6) 2015.Infusion ended: (b)(6) 2015 at 9:30pm.The patient's family member initially reported that the patient was experiencing increased pain the day after surgery.Thirty three hours after the surgery, the patient also experienced symptoms of "buzzing in ears", metallic taste in mouth, nausea, vomiting and shortness of breath.The patient was advised to clamp the pump's infusion and to contact the doctor.It was reported later by the patient's family member that the patient was doing much better and was no longer experiencing shortness of breath nor metallic taste in the mouth.The pump was removed.Additional information was received on 07/07/2015.The patient awoke on (b)(6) 2015 feeling a lot better with no further symptoms and the patient's family member removed the pump in the am on (b)(6) 2015.The patient's family member reported that the pump was not empty at the time of removal.The pump is available for return.

Manufacturer Narrative

(b)(4).The device was reported to be returning for an evaluation and at this time is pending return.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Device return anticipated.

Manufacturer Narrative

Method: a visual observation, infusion verification test, flow rate accuracy test, pressure pot test, and a review of the device history record (dhr) was conducted.Along with a review of the instructions for use (ifu).And use review.Results: a partial full pump sample was received in our lab.Infusion was immediately observed at the soaker catheters when opening the pinch clamps.The pump was refilled with 0.9% of saline to the nominal value.The soaker catheters were removed and the flow accuracy test was performed.After 50 + hours of testing, dual line #1 yielded a flow rate of 1.86ml/hr and is within specifications with a 15% tolerance.Dual line #2 yielded a flow rate of 1.74ml/hr and is within specifications with a 15% tolerance.The combined flow rate is 3.60ml/hr and is within specifications.A pressure pot test was performed for this sample on the flow restrictors without the filter.The tubing was detached from the pump and connected to a pressure gauge.The flow restrictor dual line #1 yielded a flow rate of 2.04ml/hr which is within the specification with a 15% tolerance.The flow restrictor dual line #2 yielded a flow rate of 1.95ml/hr which is within the specification with a 15% tolerance.The combined flow rate is 3.99ml/hr which is within specifications.The device history record (dhr) was evaluated.Based on the dhr review for the reported lot number there were no non-conformance reports, reworks or special conditions during product manufacturing, the production lot met all manufacturing and quality specifications.According to the ifu, several factors may affect the flow rate such as fill volume, temperature, viscosity of the drug solution, pump position, storage time and external pressure.Flow rates may vary due to: fill volume.Filling the pump less than the labeled volume results in faster flow rate.Filling the pump greater than the labeled results in slower flow rate.Viscosity and/or drug concentration.Pump position - position the pump at approximately the same level as the catheter site: positioning the pump above this level increases flow rate.Positioning the pump below this level decreases flow rate.Temperature the select-a-flow* device should be worn outside clothing and kept at room temperature.To ensure flow rate accuracy, do not place heat or cold therapy in close proximity to the flow controller.Temperature will affect solution viscosity, resulting in faster or slower flow rate.Select-a-flow* device have been calibrated using normal saline (ns) as the diluent and room temperature (22°c, 72°f) as the operating environment.Flow rate will increase approximately 1.4% per 1°f/0.6°c increase in temperature and will decrease approximately 1.4% per 1°f/0.6°c decrease in temperature.If refrigerated, allow pump to reach room temperature before using.It may take approximately 8-18 hours for a pump to reach room temperature.(see table) storage.Storage of a filled on-q* pump for more than 8 hours prior to starting infusion may result in a slower flow rate.External pressure external pressure such as squeezing or laying on the pump increases flow rate.Conclusion: the sample evaluation and dhr review was performed and no defects were found.It was reported that a patient developed a reaction following use of the pump, the assignable cause of this incident is unknown.The patient started experiencing all the symptoms (33 hours after use).When the sample was received it was partially full, we cannot estimate if the pump over infuse during the time of use.However, when tested the pump performed within specifications during the flow accuracy and pressure pot testing.During the use review it was noted that the drug used might be a potential contributor as ringing in the ears and metallic taste are the common side effects of using local anesthetics.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending purposes.

• Brand Name: ON-Q PUMP 270ML, 4ML/HR (2+2 DUAL SITE)
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4939691
• MDR Text Key: 14310628
• Report Number: 2026095-2015-00207
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: P270X4D
• Device Catalogue Number: 101367202
• Device Lot Number: 0202066564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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 Age: 39 YR
• Patient Weight: 59