MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC 600ML, 2-14ML/HR SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number CB6004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Chest Pain (1776); Pain (1994); Pneumonia (2011); Respiratory Distress (2045)

Event Date 07/09/2015

Event Type  Injury  

Event Description

Fill volume: 600ml, flow rate: 8ml/hr, procedure: rotator cuff surgery, cathplace: interscalene, expected infusion period: 3 days, date infusion began: (b)(6) 2015 in am, date infusion ended: (b)(6) 2015 at 6:00pm.It was reported that a patient experienced pneumonia manifested by chest pain and shortness of breath subsequent to pain management therapy with a pump.The patient reported that from the time that the patient returned home from the facility the patient experienced pain in her side.After being home less than 24 hours, the patient sat up and could not breathe; the patient also experienced chest pain and was then taken to the er.It was unknown if the patient had taken the same pain medication in the past.The patient was diagnosed with pneumonia and returned home and was taking antibiotics.The patient's condition was reported as stable with no chest pain.48 hours later the pump was empty and the pump was removed by the patient's family member.The patient did not adjust the flow rate during the infusion.The device is available for return.Additional information was received on 07/14/2015.The patient went to the er on (b)(6) 2015 at 11:15pm and was released the following day on (b)(6) 2015 at 4:15am when the o2 sats became normal.The patient stated that instructions for use of the pump were not provided.The infusion was expected to end on (b)(6) 2015.The patient was originally discharged with supplemental hydrocodone (tylenol 3) for pain; however, the patient did not take the first dose until after the infusion completed.The patient was never diagnosed with a urinary tract infection.Additional information was received on 07/30/2015.The patient reported that she is fully recovered and is feeling much better.

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 lot number was performed.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.Device return anticipated.

Manufacturer Narrative

Method: the device was never returned for analysis and testing.A use review was performed and review of the instructions for use (ifu) was performed.Results: as no device was received, testing results are not available.The ifu provides cautions regarding flow rate and medication dosage.Per the instructions for use (14-60-613-0-04), the onq pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and/or pain management.Flow rate is adjustable.Medication dosage should be based on maximum flow rate.The amount of medication over the therapeutic period and delivery time can vary by as much as 20%.Take this variance into consideration when determining medication delivery.Regardless of the prescribed flow rate, only fill the pump with medication dosage that is appropriate to administer at the maximum flow rate.There is no indicator of pump infusion status, therefore, use caution where over-delivery of medications could result in serious injury or death.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 at approximately 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.The saf 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.External pressure such as squeezing or laying on the pump increases flow rate.Conclusion: the root cause of this incident is unknown, according with the information provided the device was reported to present a fast flow condition during patient use.However, no sample was provided in order for an evaluation to be performed to confirm the condition or determine root cause.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 trend reporting systems for monitoring, tracking and trending.

• Brand Name: ON-Q C-BLOC 600ML, 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: 4957891
• MDR Text Key: 6192682
• Report Number: 2026095-2015-00210
• 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,Health Professional,Company Representative,company representati
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/10/2015

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: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CB6004
• Device Catalogue Number: 101347600
• Device Lot Number: 0201252630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2013
• 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: HYDROCODONE
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 75