MAUDE Adverse Event Report: HALYARD/AVANOS MEDICAL, INC. HOMEPUMP C-SERIES ELASTOMERIC PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number C270020

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/06/2020

Event Type  malfunction  

Event Description

Pt arrives on monday for a infuser to run until friday.Pt shows up on 2-6 and product empty.Fda safety report id # (b)(4).

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD/AVANOS MEDICAL, INC.
• MDR Report Key: 9694133
• MDR Text Key: 179297761
• Report Number: MW5092908
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: C270020
• Device Lot Number: 0203068909
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 117