MAUDE Adverse Event Report: KIMBERLY-CLARK HOMEPUMP ECLIPSE

Model Number E102000

Device Problems Deflation Problem (1149); Failure to Infuse (2340); Defective Device (2588); Application Program Problem: Medication Error (3198)

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

Event Date 09/21/2015

Event Type  malfunction  

Event Description

Patient was dispensed #14 cefepime 2gm in 100ml normal saline in the eclipse 100ml/200ml/hr devices.Patient returned 1 dose for replacement on (b)(6) 2015 as he tried to infuse that morning's dose and the eclipse did not fully deflate.Patient states he was hooked up to the medication with the clamp open for over 2 hours and when disconnected, there was not any medication dripping from the end but there was still medication left in the elastomeric device.The patient returned 3 more doses that did not fully deflate the following week.One defective dose was on (b)(6) 2015 am.Patient did not give specific date and time of other 3 defective doses but would have been the week of (b)(6) 2015 thru (b)(6) 2015.Patient stated that he would try to infuse the medication and would disconnect after 2 hours if it did not fully deflate.

• Brand Name: HOMEPUMP ECLIPSE
• Type of Device: HOMEPUMP ECLIPSE
• Manufacturer (Section D): KIMBERLY-CLARK; roswell GA 30076
• MDR Report Key: 5187383
• MDR Text Key: 29943620
• Report Number: MW5057483
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• 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: 0202209895
• 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
• Patient Age: 60 YR
• Patient Weight: 109