MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN ELASTOMERIC PUMP

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Respiratory Distress (2045)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

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.Root cause could not be determined.All information reasonably known as of 06-may-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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: unknown, flow rate: 14 ml/hr, procedure: right shoulder surgery, cathplace: side of neck.A report was received from the patient stating the pump had been off for a week, however she was having a hard time breathing.She also claims that she was experiencing shortness of breath while the pump was infusing.When the patient called the manufacture's hotline nurse the hotline nurse advised the patient to clamp the device tubing and call her doctor.The patient clamped the tubing and called the on-call doctor who informed her to lower the rate, which was at 14 ml/hr during that time.The patient continued to use the pump and continued to have shortness of breath, therefore, the pump was discontinued.Eight days after the device was discontinued the patient continued to have shortness of breath.The patient was on other pain medications, but stopped using them on friday, (b)(6) 2018.Due to the severity of the symptoms the hotline nurse advised the patient to go to the emergency room or call her doctor.Additional information received 25-apr-2018 stated the patient went to the emergency room (er) today.She spent almost all day at the er.The er staff performed many tests and also checked to see if she had blood clots.All tests came out negative and the er did not find anything wrong with the patient.They informed her that her oxygen (o2) levels were stable.The er staff suggested the patient to see her family doctor and if the issue persists to come back to the er.The patient did not know what type of medication was in the pump.She knew that it was some type of anesthetic.The patient had not had any anesthetics in the past.The patient stopped taking oral pain medication on (b)(6) 2018.The patient confirmed that the pump was discontinued on (b)(6) 2018.This was before the pump was completed.It was discontinued due to the shortness of breath.Therefore, she did not continue the pump after the symptom of shortness of breath.The pump was started on (b)(6) 2018, friday.The patient was to leave the device in for no longer than 3-days but ended up taking it out on (b)(6) 2018, sunday.No additional information was provided.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: UNKNOWN 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-1b; fraccionamiento rubio; tijuana, bc 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7495554
• MDR Text Key: 107633937
• Report Number: 2026095-2018-00053
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 04/14/2018

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: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NARCO, EVERY 5-HOURS FRO MODERATE PAIN.; PERCOCET 325 MG, 2 EA, Q5-HRS FOR MODERATE PAIN.
• Patient Outcome(s): Other