MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ECLIPSE HOMEPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number E102000

Device Problems Improper Flow or Infusion (2954); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Eclipse homepump 100 ml, 200 ml/hr (e102000, lot 0202989019] was filled with 80 ml of 0.9% sodium chloride.Upon disconnecting the repeater pump tubing from the inlet port, the contents bubbled up from the inlet port and were expelled within 5-7 minutes.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. ; alpharetta GA 30004
• MDR Report Key: 8191376
• MDR Text Key: 131476222
• Report Number: MW5082499
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/19/2018

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 Model Number: E102000
• Device Lot Number: 0202989019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• 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