MAUDE Adverse Event Report: KIMBERLY-CLARK ECLIPSE HOMEPUMP

Model Number E252500

Device Problem Particulates (1451)

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

Event Date 06/15/2016

Event Type  malfunction  

Event Description

Upon filling eclipse homepump 250 ml volume, 250 ml/hr, model # e252500, lot 0202379083 with 0.9 percent sodium chloride, an irregular-shaped particle or stain was noticed 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: 5744513
• MDR Text Key: 48117602
• Report Number: MW5062989
• 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: E252500
• Device Lot Number: 0202379083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• 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