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

Model Number E102000

Device Problems Crack (1135); Leak/Splash (1354); Noise, Audible (3273)

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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Upon pharmacist final check prior to dispensing, there was a hissing sound and one eclipse homepump (model # e102000, lot 0202735344) filled with ceftriaxone 2 grams/ 0.9 percent sodium chloride leaked.The tubing is cracked near the base of the reservoir.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7037456
• MDR Text Key: 92313897
• Report Number: MW5073359
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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: 0202735344
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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