MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP

Model Number E251750

Device Problems Device Operational Issue (2914); No Flow (2991)

Patient Problem Missed Dose (2561)

Event Date 03/22/2018

Event Type  malfunction  

Event Description

Eclipse homepump (model # e251750, lot # 0202765229) containing vancomycin 750 mg in 0.9 percent sodium chloride 250 mls would not infuse at patient home.When brought to office, rn opened clamp and it started running.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ECLIPSE HOMEPUMP
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7376856
• MDR Text Key: 103866213
• Report Number: MW5076181
• 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: 03/26/2018

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: Lay User/Patient
• Device Model Number: E251750
• Device Lot Number: 0202765229
• 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: 03/27/2018
• 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