MAUDE Adverse Event Report: HALYARD HEALTH ECLIPSE HOMEPUMP

Model Number E102000

Device Problem Particulates (1451)

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

Event Date 03/14/2017

Event Type  malfunction  

Event Description

Upon filling the eclipse homepump 100ml with 90ml of 0.9% sodium chloride, the pharmacy technician noticed 2 particles within the elastomeric membrane.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ECLIPSE HOMEPUMP
• Manufacturer (Section D): HALYARD HEALTH; irvine CA 92618
• MDR Report Key: 6428091
• MDR Text Key: 70804510
• Report Number: MW5068620
• Device Sequence Number: 1
• Product Code: MEB
• 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: 03/20/2017

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: 0202546316
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2017
• 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