MAUDE Adverse Event Report: KIMBERLY-CLARK ECLIPSE HOMEPUMP

Model Number E102000

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2016

Event Type  malfunction  

Event Description

Upon filling eclipse homepump, model #e102000, lot # 0202345179, 100 ml volume, 200 ml/r, a particle was notified within the reservoir near the base of the pump.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ECLIPSE HOMEPUMP
• Manufacturer (Section D): KIMBERLY-CLARK; roswell GA 30076
• MDR Report Key: 5744512
• MDR Text Key: 48116958
• Report Number: MW5062988
• Device Sequence Number: 1
• Product Code: FRN
• 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: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• 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: 0202345179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1