MAUDE Adverse Event Report: AVANOS MEDICAL INC. ELECTRONIC INFUSION PUMP; ELECTRONIC INFUSION PUMPS & SYSTEMS

Model Number 220326

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Numbness (2415)

Event Date 02/11/2023

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 09-mar-2023 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).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.

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start date: (b)(6) 2023.It was reported "approximately 300cc of fluid in the bag and when i woke up early the next morning around 4am the bag was empty.Initially the inside of her leg from groin to ankle was numb but currently the numbness is resolving." the patient denied any sign and symptoms of local anesthetic toxicity: no ringing in ears, metallic taste in mouth, dizziness, etc.

Manufacturer Narrative

The device history record for the reported lot number, e913601, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 08-may-2023 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).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.

• Brand Name: ELECTRONIC INFUSION PUMP
• Type of Device: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): PROVIDIEN DEVICE ASSEMBLY; av. ferrocarril # 1730 int. 16y17; parque industrial los pinos ii; tijuana, b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16517984
• MDR Text Key: 311073504
• Report Number: 3011270181-2023-00016
• Device Sequence Number: 1
• Product Code: LDR
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 220326
• Device Catalogue Number: N/A
• Device Lot Number: E913601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 70 KG