MAUDE Adverse Event Report: I-FLOW HOMEPUMP ECLIPSE

Lot Number 0202140711

Device Problem Delivery System Failure (2905)

Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Arthralgia (2355); Neck Pain (2433); Sleep Dysfunction (2517); Underdose (2542)

Event Date 12/15/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, i started my infusion of velaglucerase-alf (vpriv) with an i-flow, llc homepump eclipse pump, 100ml at 100ml/hr.Lot #0202140711.With about 10-15ml left to infuse, the pump completely stopped dispersing/emptying the drug.I tried putting in another 10ml of saline hoping it would push through, but nothing.I contacted my shire case manager and my pharmacy, but no one returned mine, nor shire's inquiries on what to do.I had to throw away the rest of the drug, and i did not get my full dose.On (b)(6) 2015, a second i-flow homepump eclipse pump with lot number 0202140711 failed, this time with half of the medication trapped inside.I called the 24 hour hotline at i-flow and spoke with a nurse who confirmed there was no sterile way to retrieve the drug out of the pump.This video was taken when it was at about a 12 second drip: https://youtu.Be/tvu9jjyvlx0.I had to throw away half of my medication this time, which meant i only got about half of my medication infused.I have gaucher's disease type 1.Not receiving my full dose of medication has caused me side effects that interfere with my job and personal life.I have severe fatigue, bone and joint pain, headaches, and neck aches.I have to nap in the middle of the day because i cannot stay awake.I am missing work because of this.My dose of vpriv is (b)(6) per dose.It only has a 24 hour shelf life once mixed.No one from i-flow or my pharmacy got back to me with what to do until days after the drug expired, still trapped in the pump.I-flow requested i send them the 2 failed pumps, which i did.I have not received a response.I can supply photos if you need.

• Brand Name: HOMEPUMP ECLIPSE
• Type of Device: HOMEPUMP ECLIPSE
• Manufacturer (Section D): I-FLOW
• MDR Report Key: 5340869
• MDR Text Key: 35011953
• Report Number: MW5058814
• Device Sequence Number: 2
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0202140711
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 61