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

Model Number E102000

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Information (3190)

Event Date 04/02/2018

Event Type  malfunction  

Event Description

Eclipse homepump (model # e102000, lot # 0202850367) containing ceftriaxone 2 grams in 0.9 percent sodium chloride 100 mls where tubing connects to the filter is split and causes the medicine to leak when unclamped.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERUIC
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7464475
• MDR Text Key: 106742399
• Report Number: MW5076778
• 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: 04/13/2018

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: E102000
• Device Lot Number: 0202850367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2018
• 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