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

Model Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Vomiting (2144)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 06 may 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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 146 ml, flow rate: 5ml/hr, procedure: unknown, cathplace: central venous access, infusion start time: (b)(6) 2019 at 1300, infusion stop time: (b)(6) 2019 at 1500.It was reported that the infusion finished in 15 hours.Patient reported abdominal pain and vomit and went to the hospital.Exam results show evolution to acute pancreatitis.The pump was not refilled and it was primed before connecting to the patient.No air bubbles/kinks were reported in the tubing.

Manufacturer Narrative

The device history record for lot 0202990564 was reviewed and the product was produced according to product specifications.Root cause could not be determined.All information reasonably known as of 16 jul 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 halyard health 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
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8583767
• MDR Text Key: 144436828
• Report Number: 2026095-2019-00077
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135682
• UDI-Public: 30680651135682
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: Lay User/Patient
• Device Expiration Date: 11/08/2020
• Device Model Number: C270050
• Device Catalogue Number: 101356800
• Device Lot Number: 0202990564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/17/2019
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL