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 Date 11/08/2018

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 06-dec-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).Device not returned.

Event Description

Fill volume: 146 ml; flow rate: 5 ml/hr; procedure: unknown; cathplace: unknown.It was reported that medication in an elastomeric pump was supposed to infuse over a twenty four hour period, but instead completed it's infusion in fourteen hours.The patient returned to the facility ten hours early to have the pump removed.There was no patient injury.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 08-jan-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 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 lot number was received.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 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 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

One homepump, 270x5, was received.The tubing was cut a few inches distal to the blue connector (base of the pump) to drain the medication with the pinch clamp closed.The pinch clamp was opened, and medication flowed from the pump.Pressure pot testing was performed at 5ml/hr for a 40.5-hour interval, yielding a flow rate of 4ml/hr, 80.07%.Flow rate accuracy test was performed at 5ml/hr for a 40.5-hour interval, yielding a flow rate of 5.35ml/hr, 106.95%, which met specifications with a +/-15% tolerance.The evaluation summary concluded that the flow rate was within specification for flow rate accuracy.The root cause could not be determined.No information was provided in regards to use conditions, it is unknown if user or facility conditions were contributors to the reported incident.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of (b)(4) 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 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.

• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8139220
• MDR Text Key: 130621399
• Report Number: 2026095-2018-00155
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2020
• Device Model Number: C270050
• Device Catalogue Number: 101356800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2019
• Patient Sequence Number: 1
• Treatment: FLOROURACIL