MAUDE Adverse Event Report: HALYARD - IRVINE; ELASTOMERIC PUMP

Model Number ASKU

Device Problem Infusion or Flow Problem (2964)

Patient Problems Respiratory Distress (2045); Reaction (2414)

Event Date 11/12/2015

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 reporter was unable to provide a valid lot number; thus, the device history record (dhr) review cannot be conducted.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.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.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 not received for evaluation.

Event Description

Fill volume: asku.Flow rate: 10 ml/hr, later changed to 4 ml/hr.Procedure: right rotator cuff repair.Cathplace: right neck area.Infusion started: (b)(6) 2015 at 9am.Infusion ended: (b)(6) 2015, unknown time.It was reported by via the hotline from the patients partner on (b)(6) 2015 that the patient was experiencing difficulty speaking, metallic taste in mouth and difficulty taking deep breaths.The partner was instructed to clamp the catheter to pump immediately and call the anesthesiologist.Patient was discharged home approximately 3pm mst with rate of 10ml/hr, then rate was decreased to 6ml/hr when symptoms started, approximately 2 hours after discharged.Additional information received on 11/13/2015: partner stated that she called the anesthesiologist and he instructed her to remove the catheter and begin oral pain medications.Partner reported that the anesthesiologist thought her symptoms were related to the local anesthetic in the infusion pump and would subside within a few hours.Partner reported that patient was able to sleep most of the night and symptoms had completely subsided in the morning upon awakening.It was reported that pain is worse than the previous day, but controlled with pain medication.Pump contained bupivacaine 2%.Additional information received on 11/18/2015: patient provided additional details of the incident.She states the incident occurred on (b)(6) 2015 where the pump and catheter was placed around 9am.Catheter was placed in her neck area on the right side after right shoulder surgery.She was discharged home around 3pm on that same day.She states that she was told that her oxygen level was a little low but they discharged her home anyway with home oxygen.Around 5:30pm that day, she lost her voice totally and could not mumble a word, her throat was tight and feeling as if it would close, and she had difficulty taking deep breaths.She further states that her symptoms did not fully resolve until the next morning.She did not seek further medical attention that day but kept the oxygen in use throughout the night.Patient states that she does have allergies to medications such as sulfa and antibiotics but has never had any issues with local anesthetics or other pain medications in the past and she has had 12 previous surgeries.She does carry an epi pen with her but did not use it with this incident.With the onset of the symptoms mentioned above, her partner, immediately called the hotline and decreased the flow rate from 10 ml/hr down to 4 ml/hr.She was then instructed by the hotline nurse to call her physician which she did.Physician instructed her to remove the pump and the catheter.Partner removed the catheter without any issues.Patient also mentions that she was receiving oral pain medication as well of oxycodone 5 mg.Patient believes she took 3 tablets that same day.Her prescription states that she can have 1-3 tablets every 3 hours as needed for pain.She states that currently she feels ok and her next doctors appointment to follow up is on 11/23/2015.No further information was provided.Device is available for return.

• 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. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5275668
• MDR Text Key: 32986941
• Report Number: 2026095-2015-00351
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/13/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 82