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

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Respiratory Distress (2045); Blurred Vision (2137)

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the actual device was received for analysis.A visual inspection and a review of the device history record (dhr) is in progress.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusion: 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 trend reporting systems for monitoring, tracking and trending.

Event Description

Fill volume: asku, flow rate: 4cc/hr to 6cc/hr to 2cc/hr, procedure: l rotator cuff and tendon repair, cathplace: interscalene block.It was reported on (b)(6) 2015 by the patient that he had his surgery, was given a 24 block and the pump was set at 4cc/hr.When he went home.It was reported that around 3am, patient reported to have some break through pain and turned the pump up to 6cc/hr.Patient then stated " i read through your patient brochure"."i had and still have but not as intense- every reportable side effect"."i had blurry vision, difficulty breathing, ringing in my ears,metallic taste in his mouth, droopy eyes, and a severe headache." patient stated he called the hospital and they told him to turn off the pump and restart it at noon.The patient reported that at 11am mountain time that his vision has improved, and the headache was not so bad, still has ringing in his left ear and no metal taste.The patient reported that he had the pump at 2cc hour because he was "afraid to turn it off." patient also stated the strap across his shoulder was heavy and uncomfortable and he did not like wearing the shoulder carrier.Patient was instructed to clamp the pump as the crna has instructed and turn it to zero, call anesthesia back and discuss whether or to restarting it at noon or to pull device and take orals.Patient was instructed that if his symptoms return or get worse to call 911.Patient was told that he can call back if he has any other complaints but reminded him to call his physician for medical advice and assistance for his symptoms.Patient reported pain level to be about 2-5 at the time of the call.The crna at the hospital was contacted, who gave a different set of events.Crna stated that the dosage and block was normal, patient left without any side effects.Crna reported that the patient has "ocd" and his wife works at the hospital as a nurse and the patient did not call him, but that his wife tracked him down at the hospital to say her husband has breakthrough pain, but did not mention any adverse side effects.Crna showed wife the ultrasound and that their was not any leaks and positioning was good.Crna stated he would call the patient to tell him to remove the device and take his orals and to call his ortho surgeon if more pain medication is needed.Patient reported that he pulled the device and will save it for return.Patient stated he is doing fine.Additional information received on 1/4/2016 from the crna via email: patient was contacted and he stated that he had turned the pump back on because his shoulder was "really starting to hurt." he was advised to turn the pump off immediately.He reported those symptoms we talked about on the phone, but no distress just a little anxiety.He was walked through the discontinuation of the nerve catheter, step by step.Patient confirmed that the tip was intact and that the site looked fine.I talked with him for a few minutes and told him that this was an unusual case.I explained that if medicine was going intravascular (as his symptoms suggested) that usually there was very little pain relief or block effects in the extremity and that we would have had these symptoms sooner when the higher volume and concentration of the drug was given initially.However, with the symptoms he was describing we had to assume the worst and do what was safest for him.He verbalized understanding of all of this.I then went to speak with his wife, who is an inpatient nurse at this hospital.She said he fidgeted with the sling and the pump holder all night and that he couldn't stand all the straps and stuff across his neck.She said that he "jarred it" a few times during the night and that he has always had odd reactions to all sorts of treatments in the past, basically that nothing ever goes as planned.I explained the sequence of events and apologized for the way the whole night and morning played out, and that given all of the information we had to proceed in a way that would provide the least risk for her husband.She said she understood and sort of wrote it off as this is par for the course for him and kind of how things have gone for him in the past.No patient injury or complication was reported.Device is available for return for investigation.

Manufacturer Narrative

The device history record for the lot number, 0202137212, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.The original packaging was not returned with the device.The pump was received partially full.The pinched clamp was opened and the pump infused at all saf flow rates.The flow accuracy test was performed with the saf set to 4ml/hr.After 75 hours of testing, the pump yielded a flow rate of 3.50ml/hr, which is within specifications with a +/- 20% tolerance.Pressure pot testing was performed on the flow control tubing (selected-a-flow unit) flow rates 2ml/hr, 4ml/hr, 8ml/hr and 1ml/hr with the filter removed.The saf unit was detached from the pump and hooked onto a pressure gauge.The average bladder pressure used was 8.66psi.Flow rate 2ml/hr yielded a flow rate of 2.09ml/hr, which is within specification with a +/- 20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.02ml/hr, which is within specification with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.59ml/hr, which is within specification with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.42ml/hr, which is within specification with a +/- 20% tolerance.The investigation summary for the sample concluded that during flow accuracy test, the pump yielded a flow rate of 3.50ml/hr which was within specifications with a +/- 20% tolerance.During pressure pot testing for the flow control tubing (saf unit) without the pump, the flow rates met specifications using the average bladder pressure.A fast flow was not observed.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.

• Brand Name: ON-Q C-BLOC: 400 ML, 2-14 ML/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-18; fraccionamiento rubio; tijuana, b.c. 22115 ; MX 22115
• Manufacturer Contact: lisa clark ; 5405 windward parkway; suite 100; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5383481
• MDR Text Key: 36963498
• Report Number: 2026095-2016-00003
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202137212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• 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 Age: 61 YR
• Patient Weight: 91