MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 400 ML, 100 ML/HR (DEHP-FREE); NON-DEHP PUMP - HFR

Model Number	E401000-10
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Tachycardia (2095)
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 350ml.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the pump diffused in 1 hour 30 minutes instead of 3 hours.The product administered as 1g solumedrol in 350ml of 0.9% saline.No further information was provided.Per additional information received, "following the more rapid diffusion of corticosteroids, the patient had a slight tachycardia which faded spontaneously.Afebrile throughout his corticosteroid treatment.".
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 07 feb 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.
Additional Manufacturer Narrative
One used device was returned for evaluation.Testing of the pump by refilling it with saline revealed flow rates that were within specification.No fast flow was observed.The complaint could not be confirmed as reported.Root cause was not determined.All information reasonably known as of 15 mar 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.
Additional Manufacturer Narrative
The device history record for lot 80400720 was reviewed and the product was produced according to product specifications.All information reasonably known as of 23 feb 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.

• Brand Name: HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 400 ML, 100 ML/HR (DEHP-FREE)
• Common Device Name: 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: 13476440
• Report Number: 2026095-2022-00007
• Device Sequence Number: 5247711
• Product Code: MEB
• UDI-Device Identifier: 00193494135546
• UDI-Public: 00193494135546
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: E401000-10
• Device Catalogue Number: N/A
• Device Lot Number: 80400720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 02/15/2022; 02/28/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 02/24/2022; 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1G SOLUMEDROL
• Patient Age: 39 YR
• Patient Sex: Male