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

Model Number C270050

Device Problem Improper Flow or Infusion (2954)

Patient Problems Nausea (1970); Rash (2033)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202620030, 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 18-apr-2019 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).

Event Description

Fill volume: 241 ml, flow rate: 5ml/hr, procedure: unknown, cathplace: unknown, start date: 5:15 pm on (b)(6) 2019.It was reported the homepump was started on (b)(6) 2019 and was to infuse for 46-hours.On (b)(6) 2019 at approximately 9:00 pm the patient reported the device was empty.At 10:00pm the nursing team verified that the device was empty and the infusion was completed.The infusion was expected to be completed approximately at 3:15 pm; however, the patient reported that the infusion ended the night before.On (b)(6) 2019 the clinicians were unable to specify the exact time the infusion was completed, since it occurred before the patient arrived at the clinic.There was no reported injury and the patient was noted to be doing "good." additional information received (b)(6) 2019 stated the device tubing was kept under patient a blanket.The patient reported nausea and skin rash; however, the pharmacist noted that the patient started to use oral isosorbide during the chemotherapy intravenous (iv) infusion protocols.

• 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, GA 30004 ; 4704485444
• MDR Report Key: 8532846
• MDR Text Key: 142784548
• Report Number: 2026095-2019-00063
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135682
• UDI-Public: 30680651135682
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2019

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: 08/14/2019
• Device Model Number: C270050
• Device Catalogue Number: 101356800
• Device Lot Number: 0202620030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1