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

Model Number SE050500-10-S

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Discomfort (2330); Diaphoresis (2452)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The sample is reported to be available, but has not yet been received by the manufacturer.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.

Event Description

Fill volume: 50ml.It was reported that the pump as connected to a short 22g catheter and filled to its nominal volume with ketamine.The infusion terminated after 25 minutes instead of an hour.The patient experienced discomfort and significant sweating.Additional information has been requested but not yet received.

Event Description

Additional information received 19-jul-2021 indicated the treatment was ketamine 25mg and sodium chloride 50ml.Room temperature during infusion: 21-26 degrees celsius.Diffuser in bag, next to the infusion site.No medical treatment was required.

Manufacturer Narrative

The device history record for lot 20009646 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 06 aug 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 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.

Manufacturer Narrative

The actual complaint product was returned for evaluation.Sample was received empty and during the flow accuracy and pressure pot testing the pump and tubing yielded a flow rate within specifications.The "fast flow" complaint was not confirmed and root cause couldn't be identified since no defect was found related to fast flow.All information reasonably known as of 16 aug 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 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: HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 50 ML, 50 ML/HR (DEHP-FREE)
• Type of Device: NON-DEHP PUMP - HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12143096
• MDR Text Key: 261518234
• Report Number: 2026095-2021-00075
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494442767
• UDI-Public: 00193494442767
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: SE050500-10-S
• Device Catalogue Number: N/A
• Device Lot Number: 20009646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 08/09/2021
• Supplement Dates FDA Received: 08/06/2021; 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KETAMINE 25MG.; SODIUM CHLORIDE 50ML.
• Patient Age: 48 YR