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

Model Number CB004

Device Problem Infusion or Flow Problem (2964)

Patient Problem Toxicity (2333)

Event Date 10/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.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.(b)(4).

Event Description

Fill volume: 550 ml, flow rate: 10 ml/hr, procedure: left calcaneal and cuniform osteotomy or fusion, tarso, metatarsal flexor tendon transfer to arch gastroc slide, cheilectomy, 1st metatarsal, cathplace: popliteal sciatic block with catheter.A report was received stating a pump had malfunctioned at that time but the details were limited.Additional information received on 03-oct-2016 stated there were symptoms of sudden increased numbness and possible local anesthetic toxicity.Additional information received on 14-oct-2016 stated the patient reported that on (b)(6) 2016 he suddenly could not feel anything all the way down to his toes.At the same time, he experienced a metal taste at the back of his mouth and noted ringing in the ears.He turned the pump to zero immediately and called the doctor.A pump removal was scheduled on (b)(6) 2016.At the time of catheter removal, the pump was not empty.The reported symptoms gradually resolved except for the ringing in the ear.At that time when the environment was quiet, the patient heard ringing in the ears.Additional information received on 19-oct-2016 stated the patient reported doing well at that time.He had been allowed to go up and down the stairs once a day.During the time of use with the pump it was carried around his neck in a black pouch.It was used at room temperature and no pressure had been applied to the pump.On saturday night when he was using the pump the patient reported changing the pump rate from 10ml to 12ml.The patient felt the pain was controlled.

Manufacturer Narrative

The pump was returned partially full.The pinch clamp was opened and the select-a-flow (saf) infused at all selectable flow rates.The tubing was cut below the blue connector to drain the medication.A male and female luer were used with cyclohexanone to bond the tubing back together.The pump was refilled to nominal volume with 400ml of 0.9% saline using a baxa repeater pump.Flow accuracy testing was performed with the saf set to 14ml/hr.After 21.5 hours of testing, the pump yielded a flow rate of 7.14ml/hr which is within specifications with a +/- 20% tolerance.The pressure pot was performed on the select-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 8.0psi.The saf flow rate 2ml/hr yielded a flow rate of 1.94ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.89ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 8.48ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 14.03ml/hr which is within specifications with a +/- 20% tolerance.The evaluation 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.The root cause of the reported incident of "reaction" is unknown.The pump was returned for evaluation.Sample evaluation concluded that the pump functioned as intended and met specifications during pressure pot testing; fast flow condition was not observed.Review of the device history record (dhr) identified no issues observed during the manufacturing process which would have contributed to the incident observed.The production lot met all manufacturing and quality specifications.A use review was performed to evaluate if the product was used appropriately, comparing use conditions with the requirements of the device instructions for use and labeling information.Based on the use review, there is no evidence that the instructions for use (ifu) was not followed or that the use contributed to the incident.There is also no indication that the pump ran faster than expected.Adverse event from the use of ropivacaine is usually related to increase plasma level metallic taste, tinnitus or may be early warning signs of ropivacaine toxicity.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 complaint (b)(4).

Event Description

Additional information received via voicemail from the patient stated that his left toes (big toe and 4th toes) are still numb and have a tingling sensation just as he did on the day he removed the catheter, and his ears were still ringing.The patient stated that he reported this to his surgeon who said that the issues the patient was experiencing had nothing to do with the catheter.The patient was told that these issues might be associated with a nerve issue.The patient was offered antidepressant for the nerve pain.The lot number, 0202455578, and sample were received.Further information received from the patient stated that he was continuing to experience ringing of the ears and numbness and pain in his toes.He was also experiencing trouble sleeping because his toes hurt from touching the bed sheets.The patient was only able to sleep no more than three hours a night due to these issues.The patient stated that he spoke to his surgeon, but was directed to his anesthesiologists.The patient saw the anesthesiologist, and was provided treatment for nerve damage.The patient did not respond well to the treatment, was having reactions and was becoming frustrated.

• Brand Name: ON-Q C BLOC: 400 ML, 2-14 ML/HR SELECT-A-FLOW
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6046824
• MDR Text Key: 58605927
• Report Number: 2026095-2016-00179
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• 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: 12/13/2016

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: Other Health Care Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202455578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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: 0.2 % ROPIVACAINE
• Patient Age: 62 YR
• Patient Weight: 84