MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP SOAKER 2.5IN (6.5CM): 270ML, 5ML/HR; ELASTOMERIC PUMP

Model Number PM014

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

Patient Problems Tinnitus (2103); Sweating (2444)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was reported as not available for return and analysis.The lot number was received and a review of the device history record (dhr) was conducted for the lot number reported.Results: as the device was not available for analysis, no device testing methods were performed.For this reason results cannot be obtained.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.The instructions for use (ifu) specifies, "medications or fluids must be administered per instructions provided by the drug manufacturer.Physician is responsible for prescribing drug based on each patient¿s clinical status (such as age, body weight, disease state of patient, concomitant medications, etc.).It is the responsibility of the healthcare provider to modify patient guidelines provided with the pump as appropriate for your patients¿ clinical status and medication prescribed." the patient reported experiencing ringing in the ears.Based on the medication labeling, the use of bupivacaine can result in central nervous system reactions that are characterized by excitation and/or depression, restlessness and anxiety, dizziness, tinnitus, blurred vision or tremors.Therefore, the patient's reported experience of ringing in the ears may have been caused by the medication in the device; however, we cannot rule out the device causing or contributing to the reported incident.An historical review indicated that no other complaints were reported for the reported lot number.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.

Event Description

Fill volume: 300ml; flow rate: 5ml/hr; procedure: rotator cuff repair (rcr) ((b)(6) 2015); cathplace: interscalene nerve block; infusion started: (b)(6) 2015; infusion ended: (b)(6) 2015 at 5:00am.It was reported that a patient experienced a reaction with the use of a pump.A patient's family member reported that the patient woke up, shortly before 5:00am, sweating and complaining of ringing in the ears.The family member clamped the tubing.The symptoms resolved and the patient was reported as feeling much better after the tubing was clamped.Additional information was received on (b)(6) 2015.The patient's family member reported that the patient's symptoms dissipated sometime during the evening of (b)(6) 2015.The same day, (b)(6) 2015, the patient saw the physician and the pump was removed at approximately 1:00pm.The pump did not appear empty upon removal.The patient's condition was reported as stable.The device is not available for return.

• Brand Name: ON-Q PUMP SOAKER 2.5IN (6.5CM): 270ML, 5ML/HR
• 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 noreuga edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5079583
• MDR Text Key: 25881067
• Report Number: 2026095-2015-00230
• 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: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 11/30/2017
• Device Model Number: PM014
• Device Catalogue Number: 101363400
• Device Lot Number: 0202178014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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 Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 64