MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP

Model Number E102000

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 01/23/2018

Event Type  malfunction  

Event Description

Rejected report due to the report stating there are 2 devices that malfunctioned not 3.Two eclipse homepumps (model # e102000), containing daptomycin 500 mg in 0.9% sodium chloride 100 ml.Per rn, lot #0202835030 (tubing is broken above the filter and leaking).Lot #0202835030 (tubing where clamp was / is pinched, does not appear broken but pt was very concerned.She stated that she unclamped and couldn't tell that the meds were going in.She thought it was leaking.Upon my inspection, i don't think that it is leaking, but it does kink pretty significantly where it was clamped.).

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: ECLIPSE HOMEPUMP
• Manufacturer (Section D): HALYARD; alpharetta GA 30004
• MDR Report Key: 7224515
• MDR Text Key: 98577173
• Report Number: MW5074924
• 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: 01/25/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• 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: 0202835030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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