MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP

Model Number E101000

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 11/21/2017

Event Type  malfunction  

Event Description

The eclipse home pump (model e101000, lot # 0202650718) filled with vancomycin 500 mg /0.9% sodium chloride 100 ml would not stay connected to the pt's injection cap.Injection cap was changed and the eclipse homepump continued not to stay connected.Another vancomycin homepump was attached and it stayed connected to the pt's injection cap.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ECLIPSE HOMEPUMP
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7057365
• MDR Text Key: 92976952
• Report Number: MW5073532
• 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: 11/21/2017

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: E101000
• Device Lot Number: 0202650718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2017
• 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