MAUDE Adverse Event Report: KIMBERLY-CLARK HOMEPUMP ECLIPSE

Model Number E102000

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

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

Event Date 10/11/2015

Event Type  malfunction  

Event Description

Patient was dispensed #10 primaxin 500mg in 100ml normal saline in the eclipse 100ml/200ml/hr devices on (b)(6) 2015.Patient returned all 10 doses on (b)(6) 2015 as the first 3 doses the patient and /or nurse tried to infuse did not fully deflate.Patient states she was hooked up to the medication with the clamp open for over 1-2 hours and when disconnected, there was not any medication dripping from the end but there was still medication left in the elastomeric device.Date/time when infusion started: (b)(6) 2015 at 10:10 am, (b)(6) 2015 at 08:00 pm, and (b)(6) 2015 at 06:00 am.Date/time when infusion ended: (b)(6) 2015 at 11:15 am, (b)(6) 2015 at 09:30 pm, and (b)(6) 2015 at 08:00 am.Patient would try to infuse the medication (primaxin) and would disconnect after 1-2 hours as 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: 5187384
• MDR Text Key: 29930175
• Report Number: MW5057484
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E102000
• Device Lot Number: 0202209895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 62