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

Model Number C270050

Device Problem Infusion or Flow Problem (2964)

Patient Problem Lethargy (2560)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

He actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 27-dec-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).

Event Description

Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the first of two reports.Refer to 2026095-2019-00208 for the second event.Fill volume: 240 ml.Flow rate: 5ml/hr.Procedure: chemotherapy.Cathplace: unknown.It was reported the device was connected on (b)(6) 2019 and the incident was noted on (b)(6) 2019.The procedure being performed was a 5fu infusion for 46-hours, however, the infusion was completed in 6-9 hours.The patient was lethargic at that time.

Manufacturer Narrative

The device history record for the reported lot number, 0202962221, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 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 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 sample device was received empty.The device was evaluated and flow accuracy testing and pressure testing were performed.The results of the investigation concluded the device was within specification.The failure was not confirmed.A root cause was not identified.All information reasonably known as of 21-apr-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 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, 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
• MDR Report Key: 9533420
• MDR Text Key: 218927053
• Report Number: 2026095-2019-00207
• 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: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: C270050
• Device Catalogue Number: 101356804
• Device Lot Number: 0202962221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1
• Treatment: 5FU (3,100MG-4%)
• Patient Age: 61 YR