MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ELASTOMERIC PUMP; ELASTOMERIC HFR

Model Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Blurred Vision (2137); Taste Disorder (4422)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Fill volume: unknown.Flow rate: 8 ml.Procedure: unknown.Cathplace: unknown.Infusion start time: (b)(6) 2022 at 12pm.Infusion stop time: (b)(6) 2022 at 8am.They reported blurry vision and a metallic taste that started about an hour before they called; they stated that they had already clamped off the pump.A follow up phone call revealed that they removed pump that morning.Additional information received (b)(6) 2022, it was reported that the symptoms resolved after the pump was removed.They confirmed that they were completely fine, after the medication was stopped the symptoms decreased and then went away.It was additionally reported that they, "think they may have moved on the pump and it squeezed in too much medication.".

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 (b)(6) 2022 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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.Device not returned.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: ELASTOMERIC HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• 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: 14210452
• MDR Text Key: 290092315
• Report Number: 2026095-2022-00044
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2022

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: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/26/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 79 KG