MAUDE Adverse Event Report: KIMBERLEY-CLARK ECLIPSE HOMEPUMP; INFUSION PUMP

Model Number E102000

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2016

Event Type  malfunction  

Event Description

Upon final check of imipenem/cilastatin 500mg/ns 100 ml dose, it was noticed that a particle was between the inner and outer balloon of the eclipse homepump, 100 ml 200 ml/hr, lot #0202430485.

• Brand Name: ECLIPSE HOMEPUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): KIMBERLEY-CLARK; roswell GA 30076
• MDR Report Key: 5888364
• MDR Text Key: 52646075
• Report Number: MW5064186
• 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: 08/16/2016

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: Health Professional
• Device Model Number: E102000
• Device Lot Number: 0202430485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1