MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES; ELASTOMERIC LFR

Model Number C100005

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Anxiety (2328)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 16 sep 2019 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.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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 87 ml, flow rate: 0.5ml/h, procedure: chemotherapy, cathplace: unknown , infusion start time: (b)(6) 2019 at 1740, infusion stop time: (b)(6) 2019 at 1340.It was reported that "patient in hospital, on 7 day 5fu infusion ended 20 hours earlier than the expected, caused anxiety in patient." no injury reported.Pump was located outside patient clothing or blanket.

Manufacturer Narrative

The device history record for the reported lot number, 101356004, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated.The flow rate met specification, the failure was not confirmed.A root cause was not identified.All information reasonably known as of 27-nov-2019 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 halyard health 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 C-SERIES
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9081019
• MDR Text Key: 214562496
• Report Number: 2026095-2019-00151
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135606
• UDI-Public: 30680651135606
• 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
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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: 06/30/2021
• Device Model Number: C100005
• Device Catalogue Number: 101356004
• Device Lot Number: 0002966133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/27/2019
• Patient Sequence Number: 1