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 Asthma (1726); Chest Pain (1776); Tinnitus (2103); Peroneal Nerve Palsy (2362)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # unknown.The device history record for the lot number,0202339476, 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 bonded back together with a male and female luer.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 600ml.Flow accuracy testing was performed with the saf set to 12ml/hr.After 25 hours of testing, the pump yielded a flow rate of 10.69ml/hr which is within specifications with a +/- 20% tolerance.The pressure pot 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 7.46psi.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 3.88ml/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 13.03ml/hr which is within specifications with a +/- 20% tolerance.The investigation summary concluded that 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.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.(b)(4).

Event Description

Fill volume: 550 ml, set flow rate: 8 ml/hr to 12 ml/hr, flow rate change: rate adjusted two times up to 12ml for one hour, procedure: ankle procedure, cathplace: abductor canal block, infusion started: (b)(6) 2016 at 1:30pm, infusion ended: (b)(6) 2016 at 8am or 9am.A report was received stating the patient contacted the nurse hotline and the reported a leak and the pump emptied earlier than expected.According to the flow rate calculation, at 8ml/hr the patient should have had 150 ml left in device but the device was empty.The patient complained of leaking the night prior to this event and felt that the device infused too fast.The device emptied too quickly and the patient said that it was not under the covers and just was around her neck while sleeping.There was no adverse event associated with this incident, but the patient reported experiencing pain.The patient's condition was reported as stable.Additional information received on 4-apr-2016 stated.A call was received from the roommate of the patient who had been the caregiver.The caregiver was also the person who called the nurse hotline on (b)(6) 2016.The caregiver, reported the patient was doing well at the time of this call.The caregiver mentioned that the leak initially reported to the hotline nurse did not come from the pump or tubing, but was the wet the bulky dressing on the catheter.By the morning when the caregiver called the nurse hotline the dressing was soaked and so was the bed.The patient was taking pain medications while the pump was in use.During the pump infusion, at some point the patient reported thickness of the tongue and some ringing in the ear.At one point the patient loss sensation in the affected foot.When the pump was emptied the caregiver removed the pump and catheter from the patient.The patient had to be taken to emergency room for complaints tightness of chest and difficulty breathing.In emergency room the patient was evaluated for pulmonary embolism.The results of the evaluation were negative.The patient was treated for an asthmatic attack.The patient's care giver did not know what type of catheter was used on the patient.No additional information was provided.

• 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: 5609452
• MDR Text Key: 43698484
• Report Number: 2026095-2016-00039
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0202339476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 90