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

Model Number C270050

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 02 mar 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 inc.Complaint database and identified as complaint comp-(b)(4).

Event Description

Fill volume: unknown, flow rate: unknown , procedure: unknown , cathplace: unknown , infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 2026095-2020-00032 for the first report.It was reported that the patient's pump emptied five hours before the scheduled infusion stop time.The patient stated he experienced accelerated symptoms, but had no long term effects.

Manufacturer Narrative

Additional information added to section b5.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 07 may 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 inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, 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

Additional information received 14-apr-2020 indicated the patient is "doing well.".

• 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: 9778003
• MDR Text Key: 221029442
• Report Number: 2026095-2020-00033
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651135688
• UDI-Public: 10680651135688
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

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 Model Number: C270050
• Device Catalogue Number: 101356805
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 05/07/2020
• Patient Sequence Number: 1
• Patient Weight: 81