MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tinnitus (2103); Toxicity (2333)

Event Date 02/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.The lot number was received and a review of the device history record (dhr) was conducted for the lot number reported.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.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.Per the instructions for use (ifu) there are several factors that may affect the flow rate including fill volume, temperature, viscosity of the drug solution, pump position, storage time and external pressure.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).

Event Description

Fill volume: 550ml.Flow rate: 8 ml/hr.Procedure: left foot fusion.Cathplace: behind left knee.Infusion started: (b)(6)-2016 at 1100am.Infusion ended: (b)(6)-2016 at 0700am.It was reported by the patient that he had a reaction to the medication.About 60-hours after surgery the patient complained of ringing in the ears.The patient clamped the pump when he awoke and called nurse hotline.The nurse hotline instructed the patient to call the anesthesiologist office and keep the clamp closed.The symptoms subsided but the patient reported a "little buzzing" remaining while the tubing remained clamped.The patient was informed by anesthesiologist to wait for the ringing to dissipate and then restart the pump at half the rate.If the ringing returned then the therapy would be discontinued.The patient informed the nurse hotline he would follow-up with the doctor again.The patient called the nurse hotline and stated a second anesthesiologist contacted him and told him to restart pump at half the rate when the ringing subsided.The patient stated that he had "slight buzzing in his ears still", but it had become less in intensity.The pump was still clamped and the dial set at zero.The patient stated that the pump was about the size of a golf ball at that point.The patient stated that he would keep the clamp closed and did not plan on restarting pump.The patient stated that he would call the anesthesiologist if the ringing and buzzing in ears continued through that afternoon.The patient was informed to call anesthesiologist if the buzzing or ringing did not subside within a few hours and not to wait until that afternoon.The patient was also instructed to monitor himself for further signs and symptoms of local anesthetic toxicity.The patient stated that he had the list of signs and symptoms.The patient stated that he would not start the pump again.The patient had a family member present to help monitor for signs and symptoms of local anesthetic toxicity.Additional information received on 02-mar-2016 noted the patient called the hotline nurse and stated he never restarted the pump after speaking to the hotline nurse, as well as speaking to his anesthesiologist.The pump had a little bit of medication remaining.The patient removed the pump saturday night after speaking to the anesthesiologist.He claimed the ringing in his ears never went away.He stated that he currently had ringing in his ears at that time but it was very faint.The patient stated that he felt like the pump was working well and helped with his pain, especially when taking pain medication concurrently.He did not experience any other signs of local anesthetic toxicity.The pump was started at a rate of 8ml/hr.He turned it up to 10ml/hr and 12ml/hr at one point, but never above 12 ml/hr.He followed the anesthesiologist instructions regarding rate change.The patient informed the hotline nurse hat the pump was never squeezed nor did he lay on the pump.He kept the pump in the bag to the left of his leg right next to the catheter site.The catheter site was in his sciatic nerve, behind his left knee.The room conditions were at room temperature.The pump was placed over a blanket to ensure it never go warm.No additional information was provided.

Manufacturer Narrative

One sample device was returned.The original packaging was not returned with the device.The pump was returned partially full.Infusion was verified when setting the saf to all the flow rates.The tubing was cut 2 inches distal to the blue connector to drain the medication.The tubing was bonded back together with a male and female luer using cyclohexanone.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 400ml.The flow accuracy test was performed with the saf set to 8ml/hr.After 37.5 hours of testing, the pump yielded a flow rate of 7.01ml/hr which is within specifications with a +/- 20% tolerance.Pressure pot testing was performed on the selected-a-flow unit flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge.The average bladder pressure used was 8.13psi.The saf flow rate 2ml/hr yielded a flow rate of 1.98ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.00ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.44ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.05ml/hr which is within specifications with a +/- 20% tolerance.The investigation summary concludes that a fast flow was not observed.During the flow accuracy test, the pump met specifications.During pressure pot testing, all flow rates met specifications using the average bladder pressure.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5527487
• MDR Text Key: 41216475
• Report Number: 2026095-2016-00020
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202291915
• Other Device ID Number: APR 30, 2018
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 103