MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number CB004

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

Patient Problems Headache (1880); Hearing Impairment (1881); Tinnitus (2103); Blurred Vision (2137); Dizziness (2194); Reaction (2414); Lethargy (2560)

Event Date 05/14/2015

Event Type  Injury  

Event Description

Fill volume: asku.Flow rate: 6ml/hr.Procedure: foot surgery.Cathplace: above knee, outer thigh area.Date of surgery: (b)(6) 2015.It was reported that a patient experienced a reaction while using a pump further described as difficulty speaking, slurred speech, dizziness, ringing in ears, difficulty hearing, blurred vision, confusion, drowsiness, headache, and lightheadedness.The symptoms began the day after surgery (within 24 hours of the start of infusion) and has been ongoing all day.The incident occurred in the patient's home.The patient's husband was instructed to clamp off the pump and call anesthesia and/or surgeon right away.The patient's husband was instructed to take the patient to the er if the symptoms get worse or call 911.The pump was clamped at that time.Later on, it was reported that the patient followed-up with anesthesia and was instructed to pull the catheter.The pump was not empty at the time of removal.It was reported that the slurred speech, dizziness and ringing in ears had improved.Additional information was received on 05/14/2015.The patient reported having a sharp headache and slurred speech; however, the other symptoms had resolved.In addition, the patient reported that during infusion, the patient's foot felt hot inside and upon clamping the pump, the foot immediately cooled down.The pump was removed in the patient¿s home.The patient has not visited her doctor.The pump was kept to return for evaluation.

Manufacturer Narrative

(b)(4).Method: 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 model and lot number was 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.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: 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.

Manufacturer Narrative

Method: the device was received and tested.A visual inspection, infusion verification, flow rate testing and pressure pot testing were performed on the device.In addition a use review was conducted along with a review of the instructions for use (ifu).Results: infusion was verified on all the select-a-flow (saf) flow rates (0,2,4,8,14ml/hr).0ml/hr did not infuse.The tubing was cut to drain the medication.It was then bonded back together and refilled with 0.9% of saline to the nominal value of 400ml.The saf was set to 6ml/hr and the flow accuracy test was performed, the pump yielded a flow rate of 5.29ml/hr, which is within specifications with a +/-20% tolerance.The pressure pot testing was performed on the flow control tubing without the filter on flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr using the average bladder pressure.Flow rate 2ml/hr yielded a flow rate of 2.10ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.00ml/hr which is which is within specifications with a +/-20% tolerance.Flow rate 8ml/hr yielded a flow rate of 8.26ml/hr which is within specifications with a +/-20% tolerance.Flow rate 14ml/hr yielded a flow rate of 12.35ml/hr which is within specifications with a +/-20% tolerance.A faster flow was not observed.A review of the ifu states that a flow rate on the on-q saf pump is adjustable.Medication dosage should be based on maximum flow rate of 14ml/hr.The amount of medication over the therapeutic period and delivery time can vary by as much as 20%; therefore users are instructed to take this variance into consideration when determining medication delivery.Regardless of prescribed flow rate, users are instructed to only fill the pump with medication dosage that is appropriate to administer at the maximum flow rate.To avoid complications, users are instructed to use the lowest flow rate volume and drug concentration required to produce the desired result.There is no indicator of pump infusion status therefore, use caution where over-delivery of medications could result in serious injury or death.Flow rate is unpredictable if it is dialed between rate settings.Flow rates may vary due to fill volume, viscosity and/or drug concentration, pump position, temperature, storage, and external pressure.Filling the pump less than the labeled volume results in faster flow rate.The pump should be positioned approximately at the same level as the catheter site.Positioning the pump above this level increases flow rate.The select-a-flow (saf) 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.Flow rate will increase approximately 1.4% per 1°f/0.6°c increase in temperature.Conclusion: the investigation summary concludes that a fast flow was not observed during testing.The device performed within specifications during flow accuracy testing & pressure pot testing on all flow rates.Use conditions were assessed and it was noted that the pump was positioned above the catheter site and the infusion was given under warm conditions.The pump was not used in exact accordance with the ifu.Subsequently, it is possible that these conditions could contribute to this event.However, the patient stated that the only instructions she was given was how long to expect the pump to last and how to remove it.The patient was also taking supplemental tylenol and vicodin and the symptoms began the day after surgery (within 24 hours of the start of infusion).Based on the investigation performed a root cause for the patient¿s reported condition of reaction, cannot be determined.No defect was found during sample evaluation and a review of the device history record identified no issues observed during the manufacturing process which would have contributed to the incident observed.Information from this incident has been included in our product complaint and mdr trend reporting system.

Event Description

Total fill volume reported was 400ml's, and filled by a pre-filler.

• Brand Name: ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW
• 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: 4811901
• MDR Text Key: 5893313
• Report Number: 2026095-2015-00164
• 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
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0202026718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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: VICODIN; TYLENOL
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 56