MAUDE Adverse Event Report: KIMBERLY-CLARK ECLIPSE HOMEPUMP

Model Number E401000

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 04/08/2016

Event Type  malfunction  

Event Description

Patient was to infuse piperacillin-tazobactam 4.5 grams in 400 ml ns in an eclipse homepump 100 ml/hr; 400 ml volume iv over 4 hours.The infuse ran for 6-7 hours instead of the expected 4 hours with the 15% variance.No injury reported.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: HOMEPUMP
• Manufacturer (Section D): KIMBERLY-CLARK; roswell GA 30076
• MDR Report Key: 5608316
• MDR Text Key: 43775243
• Report Number: MW5061868
• 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

1 Device was Involved in the Event

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: E401000
• Device Lot Number: 0202245694
• 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