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 Encephalopathy (1833); Confusion/ Disorientation (2553)

Event Date 10/01/2019

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 25-oct-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

Event Description

Fill volume: 750 ml.Flow rate: 6ml/hr.Procedure: total knee.Cathplace: unknown.It was reported the patient had a knee replacement on (b)(6) 2019 at the outpatient surgery center.The nurse stated on (b)(6) 2019 the spouse found the patient in the bathroom, catatonic with the pump disconnected, empty and in her hand.The spouse stated that nothing was wet from the medication and he had no idea what happened.The spouse took the patient to the hospital emergency room (er) on the (b)(6) 2019.The patient had a computed tomography (ct scan and was admitted for encephalopathy and confusion.Additional information received 03-oct-2019 stated, "the patient was doing a little better today." 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: 9243133
• MDR Text Key: 177391157
• Report Number: 2026095-2019-00176
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 91