MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP ECLIPSE ELASTOMERIC PUMP; NON-DEHP PUMP - HFR

Model Number E401000-10

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the pump infused in 3 hours instead of the intended 5 hours.There was no visible crystallization, no beading on connection and disconnection, no patient hyperthermia, and no heat source nearby.Fill volume: 500 ml.Flow rate: 100 ml/hr.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.Per additional information received on (b)(6) 2022, there was no medical interventions or injury.There were no negative consequences.

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 (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 reported event but is relaying the information 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.

Manufacturer Narrative

The device history record for lot 20065262 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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 reported event but is relaying the information 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)(6).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: HOMEPUMP ECLIPSE ELASTOMERIC PUMP
• Type of Device: NON-DEHP PUMP - 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16062948
• MDR Text Key: 307678903
• Report Number: 2026095-2022-00143
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: E401000-10
• Device Catalogue Number: N/A
• Device Lot Number: 20065262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Treatment: SOLUMEDROL 1G IN 500ML.
• Patient Age: 71 YR
• Patient Sex: Male