MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 13-dec-2018 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).

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported that a patient's elastomeric pump ran out a day and a half too soon.The reason for the early completion could not be identified.It was noted that the correct amount of drug was added to the pump.The patient liked to keep the pump in the breast pocket of his shirt, so it was thought that might have contributed to the event but was not enough to run out that quickly.The patient also confirmed he was not in a warm environment.Additional information received on 05-dec-2018 stated that the staff was certain the volume was correct, and feels that this is a patient issue.No patient injury reported.

• Brand Name: HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP)
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta 30004 ; 4704485444
• MDR Report Key: 8163838
• MDR Text Key: 130492974
• Report Number: 2026095-2018-00170
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135682
• UDI-Public: 30680651135682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/29/2018

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: 101356800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1