MAUDE Adverse Event Report: KIMBERLY CLARK ECLIPSE HOMEPUMP

Model Number E251750

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 03/16/2016

Event Type  malfunction  

Event Description

Two (2) eclipse home pumps 250 ml volume; 175 ml/hr rate filled with vancomycin 1 gram in 250 ml swi-ns infused over 2 hours instead of 86 minutes.Iv line was okay and flushed.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: HOMEPUMP
• Manufacturer (Section D): KIMBERLY CLARK; roswell GA 30076
• MDR Report Key: 5608294
• MDR Text Key: 43767331
• Report Number: MW5061867
• Device Sequence Number: 1
• Product Code: MEB
• 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: 04/21/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• 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: 0202292718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1