MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP

Model Number E102000

Device Problem Hole In Material (1293)

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

Event Date 01/29/2018

Event Type  malfunction  

Event Description

Eclipse homepump (model # 102000, lot # 0202801727) containing invanz 1 gram in 0.9 percent sodium chloride 100 ml had a hole in it.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ECLIPSE HOMEPUMP
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7233692
• MDR Text Key: 98850555
• Report Number: MW5074997
• 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: 01/30/2018

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: 0202801727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2018
• 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