MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC 400ML, 5ML/HR + 5ML/60MIN ONDEMAND; ELASTOMERIC PUMP

Model Number CB003

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Confusion/ Disorientation (2553)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Fill volume: 550ml.Flow rate: 5ml/hr.Procedure: right shoulder replacement.Infusion started on (b)(6) 2015.Infusion ended on (b)(6) 2015.It was reported that a pump's bolus button was not latching.The patient's family member reported that the bolus button would not engage and the bolus device refill indicator was in the bottom position.The bolus button was pushed every hour and twice would not latch.The patient was not in any pain; however, the patient fell twice.Additional information was received on 06/12/2015 from the patient's family member who is a healthcare professional.Following surgery after pushing the bolus device button, the button would not latch.Prior to discharge from the hospital, the patient's family member informed the anesthesiologist that the bolus button device did not work properly.On (b)(6) 2015, at approximately 0200 , the button was pushed down and latched for the first time.The bolus device was then observed as it refilled.At 0400 the bolus button was again pushed and a click was heard and the bolus device was again observed, as it refilled.Later on, the bolus button was pushed again; however, this time the bolus button would not latch.It was reported that on both occasions when the button would not latch, the bolus button remained stuck up for over an hour.The patient's family member reported that the patient exhibited increased confusion and fell twice while receiving the infusion.After contacting the anesthesiologist, the family member received instructions to remove the device.There was still medication inside the pump after the pump was disconnected.After removing the device, the patient's mental status began to clear and the patient became steadier.There was no injury related to the 2 falls and the patient did not require medical intervention.The patient's current status was reported as stable.The device was saved for return.

Manufacturer Narrative

(b)(4).The device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) for the reported lot number was conducted.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.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.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

Methods: along with the previously reported methods, an infusion verification test and a bolus volume accuracy test were performed.Results: infusion was immediately observed upon removal of the catheter from the distal luer and opening the pinch clamp.The bolus device was refilled and the bolus button was depressed and found that the bolus button functioned properly.This test was repeated a few times; the bolus button latched properly and dispensed the medication with the finding that the bolus device had no issues refilling.There were no observed issues with the functionality of the bolus device.Furthermore, there were no kinks observed in the tubing or the pump.Bolus button testing was performed using pressure.The bolus device was detached from the pump and the tubing was bonded back together.The bolus device was attached to a pressure gauge.The bolus button safety test results yielded an average delivery amount that was within specifications.The bolus volume test results yielded an average delivery amount that was within specifications.Conclusions: the investigation summary concluded that the bolus button functioned as intended and no issues were observed.During the patient controlled analgesia safety bolus test and bolus volume testing, results met specifications using the average bladder pressure.There were no kinks observed in the tubing or pump.The report of latching issues and stuck bolus button was not observed.The instructions for use (ifu) specifies, "the bolus button will not latch except within 30 minutes of pressing the bolus button." it was reported that the patient has parkinson's disease.The ifu further 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.)." the medication being infused in the pump in conjunction with the patient's medical diagnosis and history of parkinson's disease with its treatment regime (though unknown) could possibly have contributed to the reported symptoms and outcome.However, the root cause is inclusive based on the information provided.After removing the device, the patient's mental status began to clear and the patient became steadier.There was no injury related to the patient falling and no medical intervention was required.The patient's status at the time of this report was reported as stable.An historical review indicated that no other complaints were reported for this reported incident and related to the same lot number.A technical bulletin (mk-0011) on-q pump models with ondemand bolus button was sent to the customer.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.

• Brand Name: ON-Q C-BLOC 400ML, 5ML/HR + 5ML/60MIN ONDEMAND
• 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: 4884900
• MDR Text Key: 6266117
• Report Number: 2026095-2015-00188
• 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
• Report Date: 06/11/2015

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: Patient Family Member or Friend
• Device Expiration Date: 08/31/2016
• Device Model Number: CB003
• Device Catalogue Number: 101347100
• Device Lot Number: 0201605261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• 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
• Patient Age: 69 YR
• Patient Weight: 86