MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP; ELASTOMERIC PUMP

Model Number E102000

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Date 02/01/2017

Event Type  malfunction  

Event Description

When medications arrived, one of the elastomeric devices that was to have been filled with daptomycin 800 mg/0.9% sodium chloride 100 ml in a 100 ml, 200 ml/hr homepump was completely empty and had drained out in the box.The tubing was intact and was clamped.Eclipse homepump model #102000, lot # 0202526743.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 6307457
• MDR Text Key: 66782148
• Report Number: MW5067696
• 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: 02/03/2017

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: 0202526743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2017
• 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