MAUDE Adverse Event Report: ECLIPSE HOMEPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number E252500

Device Problem Defective Device (2588)

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

Event Date 02/28/2018

Event Type  malfunction  

Event Description

Two eclipse homepumps (model# e252500, lot# 0202849857) containing zithromax 500mg in 0.9% sodium chloride 250 ml have defective inner (one containing ns only).Noticed by tech during compounding.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• MDR Report Key: 7320524
• MDR Text Key: 101890628
• Report Number: MW5075723
• Device Sequence Number: 2
• 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: 03/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E252500
• Device Lot Number: 0202849857
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2018
• 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