MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 100 ML, 50 ML/HR (DEHP-FREE); NON-DEHP PUMP - HFR

Model Number	SE100500-S
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 0001002695 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 nov 2020 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).
Event or Problem Description
Fill volume: 100ml.Flow rate.50ml/hr.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the infusion duration was 1 hour instead of 2 hours.Per additional information received 2020-10-19, the medication was 25mg ketamine + nacl to a volume of 100ml.The patient experienced unusual subcutaneous swelling as a result of the reported issue.The patient's current condition is reported as "fine." additional information has been requested but not yet received.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 15 dec 2020 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 sample was returned for evaluation.During testing it was discovered that there was leakage of fluid at the filter vent hole.Pressure pot flow rate testing was conducted, and measurement of flow included the fluid that leaked out of the filter vent hole.Taking into account the leakage, the fast flow was confirmed.The cause of the fast flow was determined to be the leak at the filter.However, the cause of the leak could not be determined.All information reasonably known as of 01 feb 2021 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, 100 ML, 50 ML/HR (DEHP-FREE)
• Common Device Name: NON-DEHP PUMP - HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10781334
• Report Number: 2026095-2020-00124
• Device Sequence Number: 11722647
• Product Code: MEB
• UDI-Device Identifier: 00193494442736
• UDI-Public: 00193494442736
• 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: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2021

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: Other
• Device Expiration Date: 02/05/2022
• Device Model Number: SE100500-S
• Device Catalogue Number: N/A
• Device Lot Number: 0001002695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 01/26/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/16/2020; 02/02/2021
• Patient Sequence Number: 1
• Patient Age: 78 YR