MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE UNKNOWN ELASTOMERIC PUMP

Model Number UNKNOWN

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

Patient Problems Diaphoresis (2452); No Code Available (3191)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

No code: almost loss of consciousness and dilated pupils.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 26-aug-2019 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 avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).The device was not returned.

Event Description

It was reported the patient's mother stated the patient, "almost loss of consciousness, dilated pupils and sweating" and she called 911.The patient's mother was able to arouse the patient and the doctor thinks the patient is okay now after paramedics came to their home.The mother clamped the pump at the doctor's request.The patient's doctor believed the patient was not on any other medications.The doctor instructed the patient's mother to remove the catheter from the patient because he said it was going to come out on that day anyhow.The anesthesiologist did not know the dose of the medication or the rate, he checked in the procedure notes and could not find any information.He was not the one who inserted the device and he is not familiar with the device.Additional information received 09-aug-2019 stated the patient was doing well and there were no long term effects.The patient was stable after the catheter was removed.The doctor was unsure if the catheter migrated but did not think the pump malfunctioned.No additional information was provided.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: UNKNOWN ELASTOMERIC PUMP
• Manufacturer (Section D): AVANOS MEDICAL - 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: 8933368
• MDR Text Key: 159610493
• Report Number: 2026095-2019-00146
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2019

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/26/2019
• 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
• Patient Age: 13 YR